Director of Regulatory Affairs CMC
| Company | BlueRock Therapeutics |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics
- At least 8-10 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products
- Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format
- 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
- Excellent written and communication skills with attention to detail
- Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission
- Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25%
Responsibilities
- Represent regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products
- Independently provide strategic guidance/input related to current regulatory requirements and expectations for cell and gene therapy CMC in support of clinical trial and marketing applications
- Independently manage and prioritize multiple complex projects
- Drive workflows related to Health Agency interactions (ie, briefing documents and responses to questions)
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from departmental head on complex topics (ie, comparability, specification changes, etc.)
- Identify, communicate, and propose resolutions to routine and complex strategic issues
- Interpret global regulations and guidance. Identify regulatory opportunities and risks
- Anticipate and communicate possible regulatory paradigm shifts
- Review and provide regulatory assessments on change controls
- Prepare and manage CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents
- Manage relationships with diverse teams in a collaborative manner
- Utilize electronic systems for dossier creation and tracking
- Support departmental initiatives, including special projects, budgeting, and authoring departmental documents
Preferred Qualifications
- Experience with combination products and device filing experience
- Experience in development, manufacturing and testing of cell therapeutics is highly desired
- Experience in supporting the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments