Director – Regulatory/CMC Program Manager
Hired talent will be responsible for leading regulatory strategy development / execution and regulatory management for early development programs based in on U.S. This position will also lead and contribute to activities in support of high-quality CMC sections of regulatory documentation.
Duties and Responsibilities
The position calls for duties that are broad and variable, with significant opportunity for advancement. Specifically, you will be responsible for:
- Leading the kick-off of projects and overseeing the execution of product development plans by continually re-evaluating direction, resources and timelines.
- Working closely with cross-functional internal stakeholders and external consultants to influence, develop and maintain alignment of program with milestones.
- Ongoing risk assessment and exercise good judgement in elevating and communicating actual or potential issues.
- Authoring IND sections and managing IND document build-out with cross-functional team leads.
- Serving as the key interactor with FDA and all other agencies for in-person meetings with responsibility for all management of formal responses to agency queries.
- Providing feedback and guidance in accordance with phase appropriate regulatory expectations.
- Leading PBG responsibilities for regulatory inspections, audits, qualifications, etc.
- Remaining current of FDA regulatory pathways and guidance’s and familiar with international agencies such as EMA and Health Canada.
- Continually identifying gaps and leading process and system improvements.
- Authorized to work in the U.S.
- M.S. with 10+ years of regulatory experience in a cellular therapeutic program, or 15+ years in a relevant field.
- Possess an open and collaborative approach with the ability to work well across dynamic teams.
- Experience in cell-based therapeutics essential, detailed knowledge of allogenic products highly desired.
- Aptitude in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy.
- A desire to work in a startup environment with demonstrated agility and ability to translate strategy into action plans.
- Proven ability to prepare and submit documents to FDA, such as Investigational New Drug (IND).
- In-depth working knowledge of US agency regulations, guidance, policies, and procedures.
- Track record of building an excellent relationship with FDA and other regulatory agencies.
- Exceptional writing, communication and presentation skills.
- Medical, Dental, Vision Insurance
- Retirement Planning (401k)
- Unlimited vacation/sick days
- Parental Leave
- Commuter Benefits and much more!