ABOUT THE ROLE We are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the manufacturing of our products in the US and globally. The incumbent will be responsible for overseeing Regulatory CMC aspects of Marea's product development, manufacturing, and eventual commercialization efforts.
The position requires a strong ability to both think strategically and manage hands on execution, working well independently and in collaboration with internal and external cross-functional teams. The position reports to the Executive Director, Regulatory Affairs and will be involved in the future development and growth of the Regulatory CMC function. The role will also serve as a member of the Tech Ops leadership team to keep CMC strategy aligned with the company's overall regulatory strategy, with a dotted-line reporting relationship to the CTO.
This is a full-time position, with a strong preference for candidates that can work on-site at least two days per week in the San Francisco-based office.
KEY RESPONSIBILITIES- Provide regulatory CMC strategic leadership to support development of Marea's programs
- Partner with key functional heads in Technical Operations (Process/Analytical/Formulation Development, Manufacturing, Quality and Supply Chain) and other cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
- Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs
- Lead CMC regulatory strategy for drug-device combination products and device constituent parts, including future pre-filled syringes and autoinjectors, in coordination with Device Development, Drug Product Development and Quality
- Serve as the Regulatory Affairs representative on CMC teams and committees
- Lead communications with regulatory agencies related to CMC strategies and issues
- Manage and implement planning, authoring, and submission of high-quality CMC-related briefing documents and CMC portions of regulatory applications in the US and globally
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; identify regulatory risks
- Maintain CMC Regulatory document control system
- Monitor regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice to company leadership and CMC teams
- Facilitate timely responses to information requests and questions from health authorities regarding CMC
- Proactively identify CMC regulatory risks and propose mitigations that help shape a balanced CMC strategy
- Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team
QUALIFICATIONS- 15+ years of pharmaceutical or biotech industry experience, at least 10 years of experience in CMC Regulatory Affairs for biologics
- Bachelor's Degree in biochemistry, chemistry, biology, or related pharmaceutical fields; advanced degree preferred
- Direct CMC Regulatory Affairs experience supporting monoclonal antibody (mAb) development is required
- Direct experience leading CMC interactions with regulatory health authorities
- Demonstrated experience creating and submitting high quality CTA/IND and BLA/MAA filings for biologics
- Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations, and ICH, FDA and EMA guidelines for biologic products
- Experience with drug-device combination products and/or device constituent parts (e.g., pre-filled syringes, autoinjectors), including familiarity with 21 CFR Part 4 cGMP requirements, design control and human factors expectations, and EU drug-device combination requirements (e.g., MDR Article 117)
- Demonstrated ability to think creatively and strategically, to interpret regulatory guidance and regulations, and to assess regulatory CMC risks and likelihood of success of various strategies
- Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
- Ability to lead and build high functioning teams
- Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
- Exceptional time and project management skills, with the ability to execute plans under pressure in a small, fast-paced environment with tight deadlines.
- Ideal candidates will have pre-commercial through launch experience, within a small company environment.
PAY RANGEThe salary range for this role is $260,000-$295,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
WORKING CONDITIONS - Prolonged periods of being at a stationary desk or working on a computer
- Assessing the accuracy, neatness, and/or thoroughness of the work assigned
- Communicating with others to exchange information
- Ability to travel as needed (up to 10%) for conferences, regulatory interactions, corporate and department-wide meetings/needs
