Midlevel FDA Associate, Reed Smith LLP

Reed Smith LLP is looking for creative thinkers and problem solvers who enjoy collaborating in a supportive team environment, and who are interested in proactively pursuing their career goals and contributing to the growth of a high-energy FDA practice.

The ideal candidate will have 4 – 7 years of law firm and/or relevant in-house experience in FDA regulatory matters, excellent academic credentials, and strong writing, research, analytical and verbal communication skills. An ideal candidate will have experience applying FDA law and regulation across strategic counseling matters, investigations, and corporate transactions involving FDA-regulated companies. Experience advising Life Sciences companies on additional compliance matters (Sunshine and transparency, HCP interactions, state marketing and compliance laws) will also be helpful. In addition to the core focus on medical products, additional experience in areas including cosmetics, food, CBD/hemp, and non-medical radiation emitting products would be welcome.

How To Apply, Please submit cover letter, resume, transcript, and writing sample to: Madison McKay Legal Recruiting Coordinator at mmckay@reedsmith.com

https://recruit.reedsmith.com/psc/HCM92PRD/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=1&JobOpeningId=505928&PostingSeq=1&

**Please note the office and position you are inquiring about in your subject line.

Regulatory Health Project Manager, FDA

FDA is seeking a Regulatory Health Project Manager who coordinates/manages the application review process for an assigned group of drug/biological products or office level programs associated with drug quality application review and facility inspections throughout the drug product lifecycle.

For more information about job description please go to :

https://www.fda.gov/media/156667/download

Chief Global Regulatory Counsel, GE Healthcare

Lead GE Healthcare Legal on product regulation and quality, partnering with the global Quality and Regulatory Affairs organization (Q&R). This role reports to the General Counsel, Products, and will be dotted line to the Chief Quality & Regulatory Officer (CQRO). The successful candidate will be on the extended executive staff of the CQRO and will be responsible for:

providing strategic legal advice to Q&R across GE Healthcare products, and advising GE Healthcare on regulatory opportunities (e.g., pending legislation, including, but not limited to, the intersection of technology, software, artificial intelligence / machine learning, and patient care), business direction, and strategic and tactical matters.

Your Responsibilities

• Partner with Q&R to identify opportunities to drive the business forward while ensuring safety and compliance, including, but not limited to, targeted, proactive strategies to influence regulatory policy in the US and other key markets for patient benefit, as well as strategically implementing new regulatory guidance
• As a core member of the GE Healthcare Product Safety Review Board (PSRB), attend PSRB meetings and advise on recall strategy and communications; review and approve recalls and complaint closures
• Counsel on response to regulator inquiries, and audit / inspection activities and responses, working with Q&R subject matter experts, relevant business personnel, and other counsel (e.g., Litigation) as warranted
• Review advertising / promotional, investor relations, and other corporate as well as product-related communications, both external and internal, that are cross-product (i.e., content relevant to more than one product modality)
• Update Q&R-focused policies and processes as well as provide regulatory advice and training in conjunction with Regulatory and Compliance
• Consult and manage outside counsel as the need arises pertaining to Q&R activities
• Your Experience
• Juris Doctor (or ex-U.S. equivalent) with active bar membership / license
• Minimum of 10 years of healthcare regulatory legal experience, with focus on the U.S. Federal Food Drugs and Cosmetics Act, at a law firm, government agency, and / or corporate legal department
• Minimum 5 years experience working in a large global complex organization
• Prioritizing conflicting demands from multiple stakeholders in a fast-paced environment
• Identifying and resolving legal issues at pace with ability to make on-the-spot risk calls
• Leading effectively in a matrixed environment
• Operating with due discretion, confidentiality, objectivity, and independence
• Digesting and distilling large amounts of information into essential elements and presenting it with excellent command of the English language
• Team player, collaborative, humble, and transparent leader
• Excellent communication and presentation skills, interpersonal skills, mature judgment, and independent thinking, with ability to interact effectively at all levels of an organization
• Excellent analytical, process management and implementation skills, sensitivity to issues, and facilitation and problem-solving skills
• High level of cultural sensitivity, flexibility, and emotional intelligence to work effectively across a global, multicultural environment
• This position can sit anywhere in the US

Desired Characteristics

• Healthcare legal regulatory experience with other country medical device regulations (e.g., China NMPA, Europe EMA)

• Medical Device Industry experience

#LI-Remote

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

As a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19.  Some GE customers currently have vaccination mandates that may apply to GE employees.

Relocation Assistance Provided: No

To Apply:

https://jobs.gecareers.com/healthcare/global/en/job/GE11GLOBALR3628438EXTERNALENGLOBAL/Chief-Global-Regulatory-Counsel?utm_source=linkedin&codes=linkedin&utm_medium=phenom-feeds

Director, Regulatory Affairs, Impossible Foods

The Director, Regulatory Affairs will join the Regulatory Affairs team in providing world class Regulatory support to achieve Impossible Foods’ mission and help ensure Impossible Foods has freedom to operate in all identified U.S. and international markets. The ideal candidate will thrive in a fast-paced environment with a broad range of activities.

You Will

• Support and assist the Regulatory/Legal departments to achieve departmental and organizational objectives.
• Act as a regulatory representative on core product development teams, communicate regulatory requirements and impacts of regulations to the development team.
• Provide guidance and expertise for packaging material compliance and claim regulations.
• Evaluate IF product formulas and labels when considering international markets where regulations differ.
• Review product labelling and marketing materials for compliance with international food agency submissions and applicable regulations.
• Support the product release process by reviewing and approving requests for product release.
• Have knowledge of toxicology and experience with US GRAS notifications and other international food safety evaluations.
• Act as liaison between the company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific, and convey all necessary detail.
• Maintain ongoing surveillance and analysis of all pertinent domestic and international regulations to ensure submission requirements world-wide are current, up-to-date, and are entered into regulatory submission database and file systems.
• Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
• Ensure that information concerning such regulations and requirements, especially new or modified, are distributed to appropriate personnel.
• Review protocols and reports to support regulatory submissions.
• Support all company initiatives as identified by management and in support of other regulatory requirements.
• Comply with company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

You Have

• BA or BS degree in applicable scientific fields such as food product regulatory, food safety, food law and/or toxicology.  MS or PhD degree in applicable field, Regulatory Affairs degree desirable.
• A minimum of 15 years of technical/regulatory experience in the food industry, with 10 years of food regulatory experience.
• Experience with biotech B2B and B2C biotech food products.
• International food regulatory experience required (US, EU, Canada, Mexico, Asia, ANZ, LA/SA, etc.)
• Ability to work within a team and as an individual contributor in a fast paced changing environment. 
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to communicate effectively at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational and follow up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
• Ability to identify and solve problems and work independently with little oversight.

#LI-REMOTE

(Colorado only*) Minimum salary of  $149,250 + (bonus for Sales Bonus Plan roles) + equity + benefits.  

Note: Disclosure as required by sb19-085 of the minimum salary compensation for this role when being hired to work based in Colorado.

At Impossible Foods, safety is our priority. Our obligation to our employees (and their families and communities) includes providing a fully vaccinated workplace. It is widely recognized that vaccination is by far the safest and most effective tool for protecting ourselves and our community against the spread of Covid-19. For the sake of our employees, their families, and communities, Impossible Foods will require vaccination by February 1, 2022 for all US-based employees who are on-site at one of IF’s facilities or co-manufacturing facilities; are in a position that requires them to be in person with co-workers, customers, clients, or contractors; or are traveling on behalf of the Company, including attending any in-person Company-sponsored event.

Impossible Foods Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 

Depending on your location, the California Consumer Privacy Act (CCPA) may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here: https://impossiblefoods.com/careers/notice. By submitting your application, you are agreeing to our use and processing of your data as required.

If the ability to work remotely is indicated, this role can be performed from any US state except for Alaska, New Mexico, Oklahoma, Hawaii, and Wisconsin.

This role is not eligible for Visa Sponsorship.

To Apply:

https://jobs.lever.co/impossiblefoods/e804f8ea-f66c-4fbf-9399-179e8cb011e0?lever-source=LinkedInJobs

Program Manager, The Sustainability Department of Salt Lake City

The Sustainability Department of Salt Lake City is looking for an energetic and passionate Program Manager who will be primarily responsible for community food systems policy and programs and other projects to support the Sustainability Department mission to protect natural resources, reduce pollution, slow climate change and establish a path toward greater resiliency and vitality for all aspects of our community. The position coordinates with other city departments and community stakeholders to improve lives and the environment through increasing access to locally grown, ecologically sustainable and healthy food. 

 

The ideal candidate will have a strong background in food system policy and programming. Experience working with populations impacted by systemic racism in Salt Lake City and a working knowledge of the interconnectedness of climate change, pollution and their impact on the food system and social justice is also highly desired.

 

PLEASE SUBMIT A COVER LETTER AND RESUME TO APPLY. (Create one file to upload in the resume section or add your cover letter in the additional documents section at the end).

 

Position Closes: March 13, 2022.  Desired Start Date: Mid-April

 

 

Responsibilities

• Plans, coordinates and leads numerous multi-faceted projects and programs to advance environmental justice, food security, local, sustainable agriculture and a vibrant local food economy.
• Researches Best Management Practices to meet city’s goals related to equity, environmental justice, and community food systems. May support or lead projects related to climate planning and resilience. Plans and facilitates meetings for internal and external collaboration, gathers stakeholder feedback, recommends internal policy and city regulations. Gathers and measures data regarding urban agriculture, food security, food waste in the city and community to determine progress and effectiveness of food policies and programs.
• Works in partnership with state agencies, local government agencies, non-profit organizations and business groups to advance Salt Lake City’s sustainability agenda.
• Facilitates multi-stakeholder meetings, workshops, task forces, committees, and boards dedicated to equity, food and environmental justice. Creates space for shared decision making with community members around environmental justice issues.
• Maintains strong lines of communication between the Sustainability Department and key staff in other departments. Motivates city departments to evaluate strategies that will strengthen the local food system and mitigate impacts of climate change while considering city budget process and decision-making process.
• Identifies financial incentives, grants and other resources outside of the city that leverage staff time and funding to achieve goals strengthening the community food systems and equity.
• Represents city in conferences and meetings with other agencies, national, state and local authorities, private industry and public groups.
• Provides written and oral presentations to local, national and governmental groups.
• Responds to media requests, citizen concerns and questions in assigned program area.
• Manages contracts and provides direction for consultants. Approves payment for services.
• Recommends annual budget for sustainability programs and projects. Monitors expenditures with regard to adopted budget.
• Performs other duties as assigned.

 

Qualifications

 

• Graduation from an accredited college or university with a Bachelor’s degree in environmental studies, public administration, planning, engineering or related field plus five years related experience. A Master’s degree may be substituted for up to two years of related experience required.
• Knowledge of current trends in sustainability issues related to climate change, air quality, energy, transportation, food security, waste and recycling.
• Knowledge of federal, state, and local environmental regulations.
• Excellent interpersonal skills and the ability to communicate effectively both orally and in writing with individuals of varied backgrounds. Ability to organize work and gain support of employees, external customers and other stakeholders.
• Proficient in computer use and the application of a variety of associated software.
• Possession of a valid state driver’s license or Utah driving privilege card. Ability to travel to various external locations.

 

 

Desired Qualifications 

• Ability to communicate effectively in Spanish, both verbally and in writing.
• Graduate-level degree in environmental science, planning, engineering, communications, or related field.
• Knowledge of current trends in sustainability issues related to climate change, air quality, energy, transportation, food security, recycling and waste reduction.
• Supervisory experience.

To Apply:

https://external-slcgov.icims.com/jobs/5742/sustainability-program-manager---food-%26-equity/job?mobile=false&width=1695&height=500&bga=true&needsRedirect=false&jan1offset=-420&jun1offset=-360

Executive Director, Seed Savers

Seed Savers is seeking a purpose-driving Executive Director to shepherd our organization to achieve our core areas of impact:

• Actively engaging diverse communities through their seed legacy and stories to illuminate the value of the broad cultural heritage that Seed Savers is dedicated to preserving and sharing.

• Building a resilient, resourced, connected seed saving community that amplifies the impact of our mission through expanded educational offerings and collaborative partnerships as well as through The Exchange.

• Collaborating with mission-aligned partners to amplify our impact internally and externally, including thriving national and regionally-based partnerships.

• Taking care of the people who take care of the seeds through investing in the well-being of our invaluable staff and board.

• Intentional expansion of our resource base to build a foundation of long-term financial sustainability in support of our mission.

• Responding to environmental change and its impacts on food systems by stewarding our collection and our farm to contribute to resilient food systems.

The complete job description, please go to :

https://www.seedsavers.org/executive-director-search

Responsibilities & Roles:

• Implement SSE’s strategic priorities by cultivating a vibrant agricultural ecosystem and representing Seed Savers as a steward of both land and seeds.

• Assess, identify, and diversify sustainable, mission-aligned revenue streams (i.e. new and developing business opportunities, partnerships, programs, and/or enterprises) that amplifies Seed Savers’ influence, products, programs, and fiscal health and viability.

• Lead (7) direct reports by effectively empowering staff, honoring our institutional history, and leveraging best practices in farm management.

• Listen, lead, and inspire by architecting a transparent framework for collaborative decision-making and information exchange both within and across departments.

• Model Seed Savers’s core values by supporting biodiversity in agriculture and responsible stewardship of land, seeds, and our talented team.

• In collaboration with the Development Director and Board of Director, develop and implement strategies to effectively meet the goals and objectives outlined in the 50th anniversary endowment campaign.

• Magnify and enrich SSE’s robust history with an innovative, action-oriented lens, establishing Heritage Farm as a "living museum" destination for gardeners, seed savers, and the broader community.

• Establish an organization-wide infrastructure of trainings, communications, resources, events, and activities that are responsive to diverse needs and perspectives, reach a diverse demographic, and contribute to a socially just and ethical seed culture.

• Center respect for our ancestors and the living legacy of the seeds entrusted in our hands for future generations to grow, adapt, and have a long-lasting place on our tables and in our hearts.

Compensation

Salary is competitive and commensurate with experience with a range $100,000 - $110,000. It also includes participation in the organization’s comprehensive benefits plan.

To Apply:

https://www.seedsavers.org/executive-director-search

Assistant Professor and Senior Attorney, Environmental Advocacy Clinic, Vermont Law School

Position Summary:

The Environmental Advocacy Clinic at Vermont Law School is hiring an Assistant Professor of Law and Senior Attorney to supervise and teach clinic students working on legal matters related to environmental advocacy. An applicant should have an enthusiasm for working with law students who are eager to learn and practice skills.

Essential Functions and Principal Accountabilities:

• Work closely with clients to develop and implement legal strategies on important environmental and natural resources issues, and develop research to support new law and policy on issues that impact the environment and natural resources.
• Collaborates with clients, prospective clients, and Clinic Director to develop and maintain docket.
• Takes primary responsibility for all aspects of their EAC matters, including litigation and administrative proceedings.
• Collaborates with and mentors more junior attorneys (when requested).
• Work with other attorneys and clinical professors/instructors to develop and teach practical legal skills to student clinicians.
• Develops, updates, and teaches seminars.
• Facilitates case reviews.
• Supervises multiple student clinicians each semester.
• Collaborate and work with technical experts as needed.
• Manage positive relationships with co-counsel, clients, and partners.
• Works with the press and helps develop communications strategies where appropriate.
• Attends and presents at relevant conferences.
• Technology management within clinic (other than when IT permission is needed).
• Attends and participates in faculty, e-faculty, and clinical faculty meetings.
• Participate actively in the dynamic VLS law school environment, including collaboration with other law school programs.

Requirements

Required Education, Skills and Experience:

• Juris Doctorate (JD) degree.
• 5-10 years or more of relevant legal advocacy experience, with substantial weight given to environmental litigation and administrative proceeding experience.
• Admission to the bar in any jurisdiction, and admission or willingness to apply for admission to the Vermont bar.
• Understanding of and appreciation for inclusion, including the ability to work with students, faculty, and staff from diverse backgrounds, identities, and viewpoints.
• Excellent research, writing, and oral advocacy skills.
• Ability to manage multiple complex legal matters, including litigation, and manage partners, students, and co-counsel effectively without extensive supervision.
• Understanding of and ability to navigate within a Windows/Microsoft Office platform, primarily using Outlook, Calendar, and Microsoft Teams. Willingness to learn and use VLS-specific learning management systems such as ExamSoft, Canvas, and others.
• Ability to maintain relationships with diverse partners.
• Ability to supervise students.
• Clinical or teaching experience preferred.
• Good team member, interpersonal skills, and a sense of humor.
• Other Requirements:
• Respect – Understanding and interest in incorporating VLS Diversity, Equity and Inclusion values into the classroom and workspace.
• Adaptability and Flexibility - Must be able to adapt to new and emerging technology as established and communicated by the law school to carry out the administrative duties associated with teaching. Willingness and ability to work remotely in emergency situations. Ability to work the occasional after-hours and weekend hours required to support students in this position. Ability to prioritize multiple tasks and deadlines and reorganize under pressure.
• Communication - talk and/or listen to convey or exchange information; communicate effectively and efficiently in written correspondence and technical correspondence in English; process and comprehend written material; exchange ideas, information, and opinions with others to formulate policies and programs and/or jointly arrive at conclusions, solutions, or dispute resolution.
• Professional Discretion - exercise thoughtful judgment and meet deadlines; develop and maintain effective professional relationships with others; function effectively under stress; adapt to changing environments; display flexibility; and function in the face of uncertainties and ambiguities.
• Collaboration - This position requires collaboration with peers and colleagues as well as students, and ability to independently manage deadlines and multiple projects.
• Service- Faculty and staff at Vermont law school provide service to students, the community, and one another through service on committees and appropriate volunteer opportunities both on-and off-campus.
• Scholarship - Faculty at Vermont Law School are encouraged to pursue research and scholarship opportunities as a critical part of their own continuous learning process.
• Safety - Willingness to participate with the Vermont Law School faculty and student community and follow Covid19 safety policies and guidelines as laid out by the One VLS Action Team based on the changing landscape of the Covid19 pandemic.
• Must be able to work legally within the United States without sponsorship.
• Physical ability to perform all essential functions of the job with or without basic accommodations.

To apply:

https://recruiting.paylocity.com/recruiting/jobs/Details/955779/Vermont-Law-School/Assistant-Professor-and-Senior-Attorney-Environmental-Advocacy-Clinic

Senior Counsel, Tyson Food

This position is responsible for providing general day-to-day legal advice to Tyson’s Dakota Dunes business with a particular emphasis on beef and pork matters, including exports. This candidate will also be responsible for ensuring regulatory compliance with United States Department of Agriculture (USDA) beef and pork rules and guidelines.

Candidates should be familiar with standard legal concepts, practices, and procedures applicable to contracting and be able to provide guidance and support to the Company’s business units for operational matters related to the interpretation and enforcement of a variety of commercial contracts.

Candidates must be able to work collaboratively with other SMEs within Tyson’s legal staff and members and its compliance organization teams. This position will periodically counsel members of senior management at Tyson’s world headquarters and elsewhere ,.The candidate must exhibit the competence and professionalism needed to earn the trust of members of the management teams.

Requirements

Education: Law degree from an accredited law school and a license to practice law in at least one jurisdiction and must be able to obtain all applicable licenses to practice law in South Dakota or successfully petition for a waiver or an inhouse special license.

Experience : At least six years of legal experience required of which five years must be in a food processing, livestock, animal feed, production or of food manufacturing environment. Extensive contract experience required and real estate experience desired. Familiarity with applicable USDA regulations as well as the Packers and Stockyards Act of 1921 is a plus. A combination of in-house or government experience and private practice experience is preferred.

To Apply:

https://tysonfoods.wd5.myworkdayjobs.com/en-US/TSN/job/Dakota-Dunes-Corp