Director, Regulatory Affairs – CMC
Rocket Pharmaceuticals
4 months ago
Remote friendly (Cranbury, NJ)
United States
Operations
Director, Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls)
Responsibilities
- Work collaboratively on development and execution of Regulatory-CMC strategies for gene therapy products.
- Develop, propose, and execute global Regulatory-CMC strategy for gene therapy products from early development to licensure.
- Lead the preparation/review of CMC submission documents, registration dossiers, and responses to health authorities (e.g., briefing packages; IND/IMPD; BLA; MAA regulatory filings).
- Serve as the CMC Regulatory lead in Health Authority interactions and meetings.
- Coordinate with cross-functional CMC, analytical, quality, and regulatory teams to create high-quality submissions.
- Represent CMC regulatory strategy at cross-functional Global Project Team, Change Management team, and governance meetings.
- Ensure CMC submissions are complete, accurate, and meet regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
- Drive Regulatory-CMC strategy for product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks.
- Advise on policy changes and whether/when to engage externally.
- Oversee development/implementation of internal policies and procedures to ensure compliance with regulatory requirements and industry best practices.
- Identify and assess potential CMC regulatory risks and develop mitigation strategies across pipelines.
Qualifications
- Minimum BS degree; advanced degree preferred (PharmD/Ph.D. or equivalent) in a relevant scientific discipline.
- 12 years Regulatory Affairs experience required (minimum 8 years with an advanced degree), preferably in the pharmaceutical industry.
- At least 8 years of CMC regulatory strategy experience required.
- Experience with biotechnology and/or gene therapy products strongly preferred.
- Experience interfacing and responding to global regulatory authorities, especially for gene therapy products.
- Knowledge of US, EU, and international regulations and ICH guidelines related to CMC gene therapy development.
- Experience preparing CMC content for major global submissions (INDs, CTAs, license applications, meeting briefing packages).
- Ability to thrive in a fast-paced environment; strong strategic and tactical skills.
- Excellent written/verbal communication and analytic/problem-solving skills.
Compensation
- Expected salary range: $204,000 to $244,000.
- Total rewards may include bonuses (short-term incentives), medical/dental/vision, life insurance, 401(k) with company match and generous vesting, paid vacation/holidays, global shutdown days, wellness resources, employee support programs, and equity awards (long-term incentives).
Responsibilities
- Work collaboratively on development and execution of Regulatory-CMC strategies for gene therapy products.
- Develop, propose, and execute global Regulatory-CMC strategy for gene therapy products from early development to licensure.
- Lead the preparation/review of CMC submission documents, registration dossiers, and responses to health authorities (e.g., briefing packages; IND/IMPD; BLA; MAA regulatory filings).
- Serve as the CMC Regulatory lead in Health Authority interactions and meetings.
- Coordinate with cross-functional CMC, analytical, quality, and regulatory teams to create high-quality submissions.
- Represent CMC regulatory strategy at cross-functional Global Project Team, Change Management team, and governance meetings.
- Ensure CMC submissions are complete, accurate, and meet regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
- Drive Regulatory-CMC strategy for product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks.
- Advise on policy changes and whether/when to engage externally.
- Oversee development/implementation of internal policies and procedures to ensure compliance with regulatory requirements and industry best practices.
- Identify and assess potential CMC regulatory risks and develop mitigation strategies across pipelines.
Qualifications
- Minimum BS degree; advanced degree preferred (PharmD/Ph.D. or equivalent) in a relevant scientific discipline.
- 12 years Regulatory Affairs experience required (minimum 8 years with an advanced degree), preferably in the pharmaceutical industry.
- At least 8 years of CMC regulatory strategy experience required.
- Experience with biotechnology and/or gene therapy products strongly preferred.
- Experience interfacing and responding to global regulatory authorities, especially for gene therapy products.
- Knowledge of US, EU, and international regulations and ICH guidelines related to CMC gene therapy development.
- Experience preparing CMC content for major global submissions (INDs, CTAs, license applications, meeting briefing packages).
- Ability to thrive in a fast-paced environment; strong strategic and tactical skills.
- Excellent written/verbal communication and analytic/problem-solving skills.
Compensation
- Expected salary range: $204,000 to $244,000.
- Total rewards may include bonuses (short-term incentives), medical/dental/vision, life insurance, 401(k) with company match and generous vesting, paid vacation/holidays, global shutdown days, wellness resources, employee support programs, and equity awards (long-term incentives).