Director of Regulatory Affairs

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Director of Regulatory Affairs

 

About Us

New Age Meats is a fast-growing Berkeley startup developing plant-based and cultivated meat. We create delicious meat made without animal slaughter – healthier for humans, animals, and the planet.

 

Job Details

The Director of Regulatory Affairs reports to the Chief Marketing Officer as part of our broader Go-To-Market plan, and is a key leadership position that oversees and is accountable for worldwide regulatory strategy and execution.

This role will build on our regulatory work, provide leadership and oversight to the development of global regulatory strategies, provide regulatory guidance, prepare critical impact documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy in line with the company's strategy and innovation pipeline. The role leads broadly in a cross-functional and multicultural environment and leverages the individual's extensive experience to represent regulatory affairs in discussions as a member of the senior management team with internal and external stakeholders.

People management experience is critical as the individual will inherit headcount across food safety, quality, and regulatory with resources growing as the company grows. Cross-functional leadership will run across R&D (bio and food), legal and commercial functions to guide and execute strategy and meet regulatory approval standards on a global basis, advancing the company's portfolio towards product approval and subsequent commercial success.

This role will also support business development activities including assessing partnership/in-licensing/out-licensing opportunities, collaborate with strategic and government partners, and support government affairs/advocacy activities.

 

Duties Include

  • Provide regulatory oversight as well as strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
  • Provide strategic and technical guidance on critical impact regulatory submissions (e.g. responses to major objections raised by regulatory authorities including product labeling).
  • Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible.
  • Champion initiatives as part of near term and long-term planning that contribute to global process improvements, which have a significant impact on to the business.
  • Strategize, lead, write, and/or supervise the development and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory-compliant submissions.
  • Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
  • Understand and communicate complex scientific concepts and regulatory guidelines to regulatory agencies and internal multidisciplinary teams
  • Ability to drive meetings with various stakeholders: (i) senior management, (ii) regulatory agencies (iii) investors, (iv) expert advisors v) collaborators and vi) project teams.
  • Represent and foster the company's 5 Core Values.

 

Experience Required

  • Food ingredient industry experience bringing novel products and ingredients to market
  • Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world (Mainly US & APAC).
  • Develop and maintain accurate food labeling information for finished products (e.g. allergens, nutrition, ingredient statements, product name, claims) to assure compliance with federal and state regulations (FDA, USDA), third-party certification standards (non-GMO project, GFCO)
  • Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
  • Experience managing and collaborating with outside partners/vendors.
  • Ability to collaborate effectively with internal and external key stakeholders.
  • Ability to review, digest, interpret and explain the regulations and guidance documents to guide project teams.
  • 10-15 years of regulatory experience, including leadership of regulatory teams.
  • Negotiation, influence, and excellent interpersonal communication skills are required.

 

Preferred Experience

  • Prior experience in a venture backed start-up environment with a balance of risk taking, navigating whitespace and advancing products efficiently.
  • Prior experience leading global regulatory teams and cross-culture/markets to advance the development and registration of programs
  • Experience communicating and engaging USDA and similar global agencies

 

Qualifications 

  • Advanced degree in a scientific discipline (M.S. Ph.D., PharmD) preferred, biology, chemistry, or related sciences. An undergraduate degree is required.

 

Benefits Include

  • Flexible insurance offerings with generous company stipend
  • Equity stock options
  • 401k with match
  • Flexible PTO
  • Sponsored lunches
  • Commuter benefits
  • Open to remote candidates 

 

Our 5 Core Values

1. Innovation for Impact

   We seek to do something new, big and different united to achieve a substantive end goal

2. Ambition with Empathy

   We attract passionate, self-motivated builders that treat their teammates with kindness, candor and understanding

3. Growth oriented Mindset

   We take chances and fail forward in order to break through convention, knowing we might not get it right the first time

4. Diversity & Inclusion builds Success

   We proactively foster a diverse and inclusive workplace that is a competitive advantage for our success

5. Integrity above All

  We are fair, ethical, candid and accountable for our actions no matter what the circumstance or situation

 

New Age Meats is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status or disability status.

 

 

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