CMC Regulatory Dossier Management Director
Exelixis
2 months ago
Remote friendly (Alameda, CA)
United States
$191,500 - $272,000 USD yearly
Corporate Functions
Role Purpose
- Provide PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects, including leading development of phase-appropriate regulatory sections and delivering documents to regulatory operations on aligned timelines.
Responsibilities
- Lead development of high-quality, phase-appropriate CMC-related submissions to regulatory authorities across multiple countries and clinical studies.
- Lead development of responses to health authority questions and documentation requests.
- Ensure appropriate archiving of source technical documentation.
- Lead review of CMC documentation (e.g., INDs, IMPDs, NDAs, BLAs) with SMEs, CDMOs, and leadership; provide content or develop documents/templates as needed.
- Track and manage external partner regulatory actions and documentation through post-approval and development-stage changes.
- Coordinate CMC changes with Regulatory Affairs CMC and other program aspects.
- Ensure regulatory compliance and risk-based manufacturing flexibility within change control and health authority requirements.
- Monitor biologics CMC regulations/guidance and assess implications to development and commercial activities.
- Implement and author processes/procedures (work instructions and company SOPs); support continuous improvement.
- Provide strategic guidance related to review committees.
- Manage people (direct reports and/or as an individual contributor).
- Lead internal preparation of CMC strategy for meetings with regulatory agencies and RFIs.
- Liaise internally with functional departments and externally with vendors, partners, and collaborators.
Supervisory Responsibilities
- Leads or manages the work of others by providing guidance to subordinates or teams.
Qualifications / Experience
- Bachelor’s (13+ years) or Master’s (11+ years) or PhD (8+ years) in a related discipline, or equivalent education/experience.
- 16+ years pharmaceutical industry and/or regulatory agency experience.
- 10+ years regulatory experience with substantial responsibility.
- Experience with biologics and ADCs.
- Prior FDA health authority/review division experience required.
- Oncology experience preferred.
Skills / Abilities
- Demonstrated knowledge of US and international regulatory requirements.
- Ability to develop technical/business solutions to complex problems and exercise strategic thinking to influence outcomes.
- Strong analytical and business communication skills.
- Ability to interpret and recommend modifications to processes/standards; maintain regulatory knowledge and communicate changes.
- Working indoors.
Benefits (as stated)
- Base pay range: $191,500 - $272,000 annually.
- 401(k) with generous company contributions; group medical, dental, vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase and long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including December winter shutdown), up to 10 sick days.
- Provide PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects, including leading development of phase-appropriate regulatory sections and delivering documents to regulatory operations on aligned timelines.
Responsibilities
- Lead development of high-quality, phase-appropriate CMC-related submissions to regulatory authorities across multiple countries and clinical studies.
- Lead development of responses to health authority questions and documentation requests.
- Ensure appropriate archiving of source technical documentation.
- Lead review of CMC documentation (e.g., INDs, IMPDs, NDAs, BLAs) with SMEs, CDMOs, and leadership; provide content or develop documents/templates as needed.
- Track and manage external partner regulatory actions and documentation through post-approval and development-stage changes.
- Coordinate CMC changes with Regulatory Affairs CMC and other program aspects.
- Ensure regulatory compliance and risk-based manufacturing flexibility within change control and health authority requirements.
- Monitor biologics CMC regulations/guidance and assess implications to development and commercial activities.
- Implement and author processes/procedures (work instructions and company SOPs); support continuous improvement.
- Provide strategic guidance related to review committees.
- Manage people (direct reports and/or as an individual contributor).
- Lead internal preparation of CMC strategy for meetings with regulatory agencies and RFIs.
- Liaise internally with functional departments and externally with vendors, partners, and collaborators.
Supervisory Responsibilities
- Leads or manages the work of others by providing guidance to subordinates or teams.
Qualifications / Experience
- Bachelor’s (13+ years) or Master’s (11+ years) or PhD (8+ years) in a related discipline, or equivalent education/experience.
- 16+ years pharmaceutical industry and/or regulatory agency experience.
- 10+ years regulatory experience with substantial responsibility.
- Experience with biologics and ADCs.
- Prior FDA health authority/review division experience required.
- Oncology experience preferred.
Skills / Abilities
- Demonstrated knowledge of US and international regulatory requirements.
- Ability to develop technical/business solutions to complex problems and exercise strategic thinking to influence outcomes.
- Strong analytical and business communication skills.
- Ability to interpret and recommend modifications to processes/standards; maintain regulatory knowledge and communicate changes.
- Working indoors.
Benefits (as stated)
- Base pay range: $191,500 - $272,000 annually.
- 401(k) with generous company contributions; group medical, dental, vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase and long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including December winter shutdown), up to 10 sick days.