Associate Director, Regulatory Affairs – CMC
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
Visit company websiteExplore more
Salary
💰 $222,435 - $240,000 per year
Job Level
About the role
- Providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products
- Oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories
- Working closely with technical CMC teams in USA and Canada, project teams
- Serving as point for interactions with global health authorities to achieve alignment on regulatory strategies
- Independently managing and prioritizing multiple complex projects
- Driving workflows related to Health Agency interactions (ie, briefing documents and responses to questions)
- Interfacing with the Health Authorities for CMC submissions and CMC-related issues
- Identifying regulatory opportunities and risks
- Anticipating and communicating possible regulatory paradigm shifts
- Reviewing and providing regulatory assessments on change controls
- Preparing and managing CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness
- Managing relationships with diverse teams in a collaborative manner
- Supporting departmental initiatives, including special projects, budgeting, and authoring departmental documents
Requirements
- Bachelor’s degree or equivalent in Regulatory Science or related field
- 6 years of experience in Regulatory Affairs, CMC
- Experience in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products
- Direct experience interfacing with regulatory authorities
- Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA and NDA/BLA/MAA
- Ability to lead regulatory CMC discussions with global regulatory authorities
- Experience preparing electronic submissions following eCTD format
- Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development
- Experience in leading the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments
- Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation
- Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations
- Excellent written and communication skills with attention to detail
- Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission.
Benefits
- Telecommuting permitted
- 25% of travel within US/Canada (some additional, limited EU travel possible)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsCMCbiologicalstherapeutic proteinscell and gene therapyregulatory filingseCTD formatregulatory strategiesmanufacturingquality control assays
Soft Skills
interpersonal skillscollaborationcommunication skillsattention to detailproject managementleadershipprioritizationproblem-solvingrelationship managementinitiative
Certifications
Bachelor’s degree in Regulatory Science