Regulatory Affairs Director

4 weeks ago

Cambridge, Massachusetts, United States BlueRock Therapeutics Full time
About BlueRock Therapeutics

BlueRock Therapeutics is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

Job Summary

We are seeking a highly experienced Regulatory Affairs Director to lead our CMC regulatory strategy and guidance for cell and gene therapy products. The ideal candidate will have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.

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 oversite 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.
Requirements
  • The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
  • 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 (preferred).
  • Experience with combination products and device filing experience also preferred.
  • Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.
  • Lead regulatory CMC discussions with global regulatory authorities.
  • 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.
  • 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.
  • Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25% is required.
About Our Company Culture

BlueRock Therapeutics is a winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023, Comparably's Award for Best Company for Diversity 2022, Comparably's Award for Best Company for Women 2022, and Comparably's Award for Best CEO 2022. We are ranked in the top 5% of companies for Overall Culture on Comparably. Our Engineering Department is also ranked in the top 5% of companies for Overall Culture on Comparably.

Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics

Follow us on LinkedIn: https://www.linkedin.com/company/bluerock-therapeutics/

Equal Opportunity Workplace

At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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