Specialist, Regulatory Affairs-Operations
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About The Position
Forge Biologics, Inc. seeks an experienced Regulatory Affairs Specialist to join our growing team. This role will be accountable for the preparation and management of CMC (chemistry, manufacturing, and control) components for dossiers and submissions of Module 2.3 and Module 3 CTD (common technical document) sections, Drug Master Files (DMFs), Site Master Files (SMFs) and related progress reports, amendments, supplemental applications. This includes continued maintenance of these CMC regulatory submissions to the FDA, Health Canada, MHRA, EU Health Authorities including EMA and other global regulatory agencies. This role works across functional groups and directly with external client teams to propose strategies and solutions. Responsibilities include coordination and management of CMC change control and related databases for clinical and commercial applications. The position will support compliance with regulatory authority regulations and interpretations with opportunities to interact with clients of Forge Biologics and global regulatory agency personnel. A strong candidate will demonstrate independent project management, document creation and lead the integration of regulatory filings with various teams including operations, quality, external clients, and external CROs and consultants in the planning, organization, and preparation of regulatory documents. Excellent written and effective verbal communication skills along with flexibility and ability to work in a fast-paced environment are a must.
