Vice President, Head of Regulatory Affairs - Metagenomi

We are hiring a Vice President of Regulatory Affairs to build our Regulatory function and define our global regulatory strategies from pre-IND to regulatory approvals across our in vivo and ex vivo gene editing product portfolio.

Reporting to the Chief Medical Officer, this role will serve as the primary point of contact representing the company to global regulatory agencies, manage content and operational aspects for all regulatory submissions, and oversee clinical (GCP) quality affairs. This person will be the company's Regulatory Head for strategy, execution, regulatory operations, and partnership with other functions. As we mature our pipeline, this person will advance therapies into the clinic and market in a high-impact role while building the function. The position will be based in Emeryville, California.  

How you’ll contribute: 

• Building and leading the Regulatory Affairs function in the development and implementation of global regulatory strategies and processes to gain global product approvals
• Serving as the primary point of contact for global regulatory authorities, regulatory inspections, and overseeing the company’s GLP/GCP vendor/site audit plans
• Educating the company on regulatory issues, recent trends in approvals, and initiating regulatory intelligence activities as appropriate
• Managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc), including the oversight of vendor activities and budgets
• Overseeing the review and approval for product packaging and labeling, and when appropriate, participating in the approval of advertising and promotional materials and activities
• Partnering with the executive leadership team on presentations to the Board of Directors, investors, potential corporate collaborators, and all other external constituents
• Contributing to the development and maintenance of a positive team-focused company culture

Must haves:   

• Minimum of BA/BS in a scientific discipline with at least 12 years of pharmaceutical and/or biotechnology industry experience – regulatory affairs certification (RAC) and/or graduate work in the life sciences/engineering preferred
• Strong leadership skills to translate corporate objectives into effective regulatory action plans
• Experience leading global regulatory organizations through critical product milestones, preferably with some experience in rare disease development involving novel regulatory strategies and novel treatment modalities 
• Experience with all phases of product development, including complex international early-stage development programs involving gene editing, gene therapy, or cell therapy products
• Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site/sponsor regulatory inspections
• Experience in developing and tracking departmental budgets
• Outstanding leadership abilities with a track record of recruiting, developing, retaining, and motivating high-performing teams
• Thorough understanding of GCP and ICH Guidelines governing the conduct of clinical trials, applicable sections of the Code of Federal Regulations, and GMP requirements
• Solution-oriented team player with executive presence and demeanor, excellent written and verbal communication skills, and outstanding analytical abilities
• Ability to adapt quickly to changing environments and priorities
• Positive attitude and high personal and ethical standards in achieving corporate goals

Metagenomi Company Values: 

Driven by innovation

Dedicated to scientific rigor

Championed by each other 

California Pay Transparency Disclosure:

This position is classified as exempt under the Federal Labor Standards Act.  This position's anticipated base salary range will be $305,000 - $365,000. Metagenomi has the right to modify this range at any time. Depending on the position offered, you will also be eligible to receive equity, bonuses, and a full range of benefits. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.