Sr. Director/VP of Regulatory

1 week ago

San Francisco, California, United States Nobell Foods Full time

Nobell Foods is creating cheese and other dairy products from plant-derived dairy proteins for the 99% of people who are unwilling to compromise on taste and price. Nobell is made up of a team of passionate scientists, explorers, and storytellers on a mission to radically change the way we make food, so its better for you, the animals and the planet. We are backed by Bill Gates client fund Breakthrough Energy Ventures, Andreessen Horowitz, and Robert Downey Jr. If you believe in our mission and are excited about our work, we would love to hear from you

Your Role:

You will lead the companys regulatory affairs, including developing and executing its regulatory strategy for its product development and commercialization activities. You will also be a key internal leader and driver of regulatory policy and strategy for our products and will provide regulatory guidance to executive leadership in all areas of regulatory affairs throughout the R&D, approval and commercialization phases of the product life cycle.

You will also work closely with teams across the company to advise on regulatory strategy and field operations compliance, prepare and manage relevant submissions with USDA and FDA, as well as manage such relationships, and provide strategic and operational guidance based on your experience and expertise.

Responsibilities:

Reporting to the Chief Legal Officer, this role will be responsible for developing and driving the execution of Nobells global regulatory strategy and providing leadership and oversight on all R&D, product development and commercialization activities at Nobell for a range of genetically engineered traits and products in soybean as well as the food products made from those soybeans.

Shape, create alignment and execute the regulatory requirements and strategy for genetically engineered traits in development through to commercial launch in collaboration with the leadership team; serve as partner to internal teams on all regulatory matters specific to their functions.

Serve as primary liaison with USDA, FDA and foreign counterparts; establish appropriate, proactive communications with agency officials to ensure expedient and efficient review and approval of submissions; lead meetings between Nobell and government agencies and prepare internal teams for such meetings.

Provide strategic and technical guidance on regulatory submissions.

Prepare and manage permits, applications and other submissions for all activities associated with the companys plantings and field operations and commercialization activities at global level; work with internal teams on the preparation of data packages required for such submissions; provide regulatory review for all permits, applications and other submissions.

Provide regulatory support for product commercialization process, including preparation of US GRAS and other international food safety evaluations, reviewing product labeling and marketing materials for compliance with applicable agency submissions and regulations and supporting the product release process.

Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for the business and product pipeline in partnership with the legal and compliance teams.

Serve as the company authority on agricultural biotechnology regulatory policies in the United States and other regions, (as needed) and play lead role in updating and preparing the company for any changes in legislation which impact the business.

Build and manage a high performing regulatory team to support our product development and commercialization goals

Lead company-wide regulatory training program in partnership with the Compliance team.

Qualifications

An M.S. or Ph.D. in a field applicable to plant science

Minimum 12+ years of relevant regulatory experience in agriculture industry

Demonstrated ability to develop and maintain excellent working relationships with USDA and FDA, including experience obtaining USDA-APHIS BRS authorizations, designing, managing and submitting data packages and dossiers to USDA/APHIS and FDA and bringing products to market via US GRAS process

Demonstrated experience working on regulated field trials in United States

Experience building teams and establishing regulatory capabilities and functions

Ability to understand and communicate complex scientific concepts and key issues to regulatory agencies and internal multidisciplinary teams

Excellent interpersonal and communication skills to partner with internal teams to drive regulatory strategy in combination with business objectives and facilitate collaboration across functions and build successful relationships with internal and external stakeholders

Entrepreneurial thinker and attitude, creative problem solver and comfortable working within a fast-paced, high-growth company

Closing:

The pay range is currently between $177,000 to $265,000 in annual gross compensation for a Senior Director level role in the Bay Area and

between $199,000 to $319,00 in annual gross compensation for a VP level role in the Bay Area. Within the range, individual pay is determined by many factors, including job-related skills, experience, and relevant education or training.

Nobell Foods offers competitive compensation, generous healthcare, dental and vision plans, 401(k) and commuter benefits.

Full time, South San Francisco, CA or Remote

#J-18808-Ljbffr

  • Director of Regulatory

    1 week ago

    South San Francisco, California, United States Andromeda Surgical Full time

    Company DescriptionAt Andromeda Surgical, we are developing autonomous robots with the goal of making surgical procedures safer, easier, and more efficient. We are starting with a urologic procedure that has superior outcomes but a steep learning curve that has limited its adoption. Our mission is to elevate every surgeon to world expert level, empowering...

  • VP, Controllership

    1 week ago

    San Francisco, California, United States Synchrony Financial Full time

    Job Listing: VP, Regulatory Reporting at Synchrony FinancialRole Summary/Purpose:The VP, Regulatory Reporting will lead the preparation of certain Federal and OCC reporting in accordance with US GAAP and instructions including but not limited to schedules within FR2900, FRY-9C, FFIEC031, FRY-9LP, FRY-11, FFIEC009, FR Y-14Q and FR Y-15, reporting directly to...

  • VP, Immunology

    1 day ago

    South San Francisco, California, United States Annexon, Inc. Full time

    Work LocationCorporate Headquarters (South San Francisco, CA) Onsite – HybridNon-local candidates will be consideredPosition SummaryWe are seeking an accomplished and visionary leader to join our team as VP, Immunology & Rheumatology – Clinical Development. The VP, Immunology & Rheumatology – Clinical Development will play a critical role in shaping...

  • VP/Director of SEO

    1 week ago

    San Francisco, California, United States Academia Full time

    is a venture backed, for profit business based in San Francisco. We have spent the last 13 years building the world's largest network for sharing and finding academic research online. With over 250MM users and nearly half of the world's academics using our platform every month, our product team develops and grows compelling products for researchers and...

  • Director, Regulatory Operations

    1 week ago

    San Diego, California, United States Avidity Biosciences Full time

    Job Title:Director, Regulatory OperationsLocation:Hybrid / RemotePosition type:FLSA:Full time- ExemptDepartment:Regulatory AffairsStrive to Bring a Profound Difference to our Patients**:At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA...

  • Director/Senior Director, Drug Product/Formulation Development

    2 months ago

    South San Francisco, California, United States IDEAYA Biosciences Full time

    We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...

  • Director/Senior Director, Drug Product/Formulation Development

    4 weeks ago

    South San Francisco, California, United States IDEAYA Biosciences Full time

    We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...

  • Director of Engineering

    2 months ago

    San Francisco, California, United States Spencer Ogden Full time

    This company develops, invests, and delivers solar photovoltaic (PV) and battery energy storage systems (BESS) projects through Engineering, Procurement, Construction (EPC) services in North America.The company brings a decade of global leadership in solar PV to deliver utility-scale power generation plants customized for local and regional energy markets....

  • Director of Engineering

    4 weeks ago

    San Francisco, California, United States Spencer Ogden Full time

    This company develops, invests, and delivers solar photovoltaic (PV) and battery energy storage systems (BESS) projects through Engineering, Procurement, Construction (EPC) services in North America.The company brings a decade of global leadership in solar PV to deliver utility-scale power generation plants customized for local and regional energy markets....

  • Director/Senior Director, Clinical Operations

    4 weeks ago

    South San Francisco, California, United States Annexon, Inc. Full time

    Work LocationCorporate Headquarters (South San Francisco, CA) Onsite - Hybrid Position SummaryThis position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure...

  • Director/Senior Director, Clinical Operations

    4 weeks ago

    South San Francisco, California, United States Annexon, Inc. Full time

    Work LocationCorporate Headquarters (South San Francisco, CA) Onsite - Hybrid Position SummaryThis position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure...

  • VP/Credit Analytics Manager

    1 week ago

    San Jose, California, United States Heritage Bank of Commerce Full time

    VP/Credit Analytics Manager Posting Date: 05/29/2024 Location: San Jose (on-site) Requisition #: HBC 24-40 Department: Credit Administration Job Summary:The VP/Credit Data Analytics Manager is responsible for data and credit portfolio analysis prepared for internal and external stakeholders including Bank executives, auditors, and regulators. The Credit...

  • Director, Clinical Quality Assurance

    2 months ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    1 month ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Executive Director, Sr. Client Partner: HC

    1 week ago

    San Francisco, California, United States NTT DATA Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertExecutive Director, SrClient Partner:HC - Roche - Life Science - Global (Remote) Date:May 5, 2024Company:NTT DATA ServicesNTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of...

  • SRS US Senior Director of Mechanical Maintenance

    1 week ago

    San Jose, California, United States Stadler Rail Full time

    Stadler has been building trains for over 80 years. With our innovative strength, flexibility and reliability we are a leading manufacturer of rail vehicles today. In addition to our Swiss locations, around employees work at several production and engineering sites and over 70 service locations in Europe, North America and North Africa.Join our team and help...

  • Associate Director, Program Management

    1 week ago

    San Diego, California, United States RayzeBio Full time

    Exciting opportunities for Senior Director Program Management positions in the United States!Chief of Staff - Senior Director, Program ManagementSr. Director of Program & Project Management OfficeMeetings and Remote - Director Program ManagementConnection Systems - Director of Program and Launch Management, AmericasRegulatory and Strategic Program Management...

  • Sr Fair Lending Compliance Analyst

    1 week ago

    San Francisco, California, United States LendingClub Full time

    Current Employees of LendingClub: Please apply via your internal Workday AccountLendingClub Corporation (NYSE:LC) is the parent company of LendingClub Bank, National Association, Member FDIC. We are the leading digital marketplace bank in the U.S., having helped our nearly 5 million members secure over $90 billion in loans to refinance high-cost debt and...

  • vp, Head of Internal Audit

    1 month ago

    San Francisco, California, United States GAP INC. Full time

    About Gap Inc.Our brands bridge the gaps we see in the world. Old Navy democratizes style to ensure everyone has access to quality fashion at every price point. Athleta unleashes the potential of every woman, regardless of body size, age or ethnicity. Banana Republic believes in sustainable luxury for all. And Gap inspires the world to bring individuality to...