Senior Director, Regulatory Affairs CMC
Zenas BioPharma
9 hours ago
Remote friendly (Waltham, MA)
United States
$220,000 - $275,000 USD yearly
Corporate Functions
Position Summary
Sr. Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) responsible for executing global regulatory CMC strategies to support clinical development of small molecule drug products; provides regulatory guidance and leads short- and long-term regulatory strategy development for assigned projects; leads writing/review of CMC sections of regulatory submissions (IND/IMPD/NLA) to meet quality expectations and company timelines; partners with Technical Operations, Quality, and Regulatory Affairs to ensure compliant agency expectations.
Key Responsibilities
- Lead development of the regulatory CMC strategy for assigned development products
- Represent RA CMC on development teams; direct interpretation/application of CMC/Quality regulations and guidance
- Prepare/coordinate/review CMC content of IND/IMPD/NDA submissions, meeting packages, and responses to agency questions/requests
- Lead teams for assigned CMC submission projects per timelines
- Provide strategic/regulatory compliance input on technical protocols, reports, and other source CMC documents
- Align regulatory CMC strategy with corporate objectives; collaborate with internal stakeholders; escalate compliance risks to Senior Management
- Maintain knowledge of US and EU regulatory guidance/regulations and competitive intelligence; communicate updates and ensure submission compliance
- Represent Regulatory Affairs CMC on cross-functional teams
- Contribute to development/maintenance of Regulatory Affairs working practices and procedures
- Perform other regulatory-related duties as assigned
Qualifications
- BS or advanced degree, preferably in chemistry or life/physical sciences
- Minimum 12 years regulatory affairs experience (5+ years RA CMC) in pharmaceutical/biotechnology
- Prior experience developing US and EU global regulatory strategies for small molecule drugs
- Knowledge of small molecule chemistry and development processes
- Prior experience compiling Module 3 CMC sections for IND/IMPD/NDAs
- Experience interacting with stakeholders (product development, manufacturing, QA, QC, supply chain)
- Ability to influence across functions and levels
- Self-motivated; able to function independently and as part of a team
- Ability to prioritize, multi-task, and work in evolving/high-pressure environments
- Strong presentation and written/verbal communication skills
- Flexibility to work non-traditional hours as needed across time zones
- People management experience preferred
Compensation/Benefits (if applicable)
- Competitive compensation and benefits package; base salary range: $220,000 to $275,000; additional total rewards include annual performance bonus, equity, full range of benefits, and other incentives.
Sr. Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) responsible for executing global regulatory CMC strategies to support clinical development of small molecule drug products; provides regulatory guidance and leads short- and long-term regulatory strategy development for assigned projects; leads writing/review of CMC sections of regulatory submissions (IND/IMPD/NLA) to meet quality expectations and company timelines; partners with Technical Operations, Quality, and Regulatory Affairs to ensure compliant agency expectations.
Key Responsibilities
- Lead development of the regulatory CMC strategy for assigned development products
- Represent RA CMC on development teams; direct interpretation/application of CMC/Quality regulations and guidance
- Prepare/coordinate/review CMC content of IND/IMPD/NDA submissions, meeting packages, and responses to agency questions/requests
- Lead teams for assigned CMC submission projects per timelines
- Provide strategic/regulatory compliance input on technical protocols, reports, and other source CMC documents
- Align regulatory CMC strategy with corporate objectives; collaborate with internal stakeholders; escalate compliance risks to Senior Management
- Maintain knowledge of US and EU regulatory guidance/regulations and competitive intelligence; communicate updates and ensure submission compliance
- Represent Regulatory Affairs CMC on cross-functional teams
- Contribute to development/maintenance of Regulatory Affairs working practices and procedures
- Perform other regulatory-related duties as assigned
Qualifications
- BS or advanced degree, preferably in chemistry or life/physical sciences
- Minimum 12 years regulatory affairs experience (5+ years RA CMC) in pharmaceutical/biotechnology
- Prior experience developing US and EU global regulatory strategies for small molecule drugs
- Knowledge of small molecule chemistry and development processes
- Prior experience compiling Module 3 CMC sections for IND/IMPD/NDAs
- Experience interacting with stakeholders (product development, manufacturing, QA, QC, supply chain)
- Ability to influence across functions and levels
- Self-motivated; able to function independently and as part of a team
- Ability to prioritize, multi-task, and work in evolving/high-pressure environments
- Strong presentation and written/verbal communication skills
- Flexibility to work non-traditional hours as needed across time zones
- People management experience preferred
Compensation/Benefits (if applicable)
- Competitive compensation and benefits package; base salary range: $220,000 to $275,000; additional total rewards include annual performance bonus, equity, full range of benefits, and other incentives.