ExCellThera is looking for a detail-oriented professional eager to grow their career as a CMC Regulatory Affairs Specialist. Key responsibilities include drafting and preparation of CMC sections of regulatory submissions, participating in establishing regulatory CMC strategies to support the development of the company’s cell therapy product(s), and providing relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met.
Roles and Responsibilities
- Author, compile, and manage CMC sections of regulatory submissions including, Investigation New Drugs (INDs) and Investigational Medicinal Product Dossier (IMPD), Clinical Trial Applications (CTAs), New Drug Submissions (NDS), Biologic Licence Applications (BLAs), and Marketing Authorization applications (MAAs).
- Critically review the source documents for consistency, completeness, and quality. Collaborate effectively with subject matter experts across ExCellThera functions in the development and review of documents and obtaining required data and supporting source documents.
- Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new cellular therapy products, to expedite submission, review and approval of global applications.
- Participate in the strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and post approval activities.
- Lead projects with cross-functional teams and act as the primary regulatory CMC contact for assigned products and projects.
- Maintain proper communication with all key partners in the functional departments of Process Development, Manufacturing, Quality Assurance, and Commercial groups to ensure timely deliverables of CMC modules that reflect the most accurate information.
Education and Experience
- Minimum Bachelor’s degree (M.S. or Ph.D. preferred) in Chemical and/or Biological Sciences or relevant discipline
- 4+ years’ experience in CMC regulatory
- Working knowledge of CMC regulatory submissions with a good understanding of current Canadian, U.S., and/or EU pharmaceutical regulatory requirements pertaining to CMC sections of regulatory filings for clinical and post-marketing filings
- Cell and gene therapy or Biologics experience preferred
- Excellent drafting skills in English (French is an asset)
- Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities
- Working in a cross functional team environment
- Excellent verbal/written communication and listening skills
- Proven planning and organizational skills and regulatory writing skills
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
- Proficiency with the Microsoft Office Suite
- Detail/accuracy oriented
- Passion for saving lives through cutting-edge medicine
- Preferred location is Montreal, Quebec