Regulatory Affairs Specialist

Responsibilities: ·        Prepare new Product Master File submissions and maintain existing product Master Files, including drafting, reviewing, updating and finalizing submissions·        Work with subcontractors to prepare documents for submission.·        Support and advise clients working on submission for the US FDA or international agencies.·        Manage communications with regulatory agencies, including meeting requests and responses to Requests for Information from US and international agencies·        Provide regulatory support during internal project development involving advanced therapy medicinal products (ATMPs), including cell and gene therapy (CGT) products Key skills and experience required:·        Strong technical background and familiarity with CMC issues involving biologics, preferably involving ATMPs / CGT products·        In depth knowledge of US FDA guidance pertaining to biologics and CGT products·        Well versed in Common Technical Document format and content·        Strong attention to detail and good technical writing skills. ·        Well versed in cGMP compliance issues and understanding of regulatory expectations during early to late-stage product development and licensure·        Ability to work collaboratively within cross-functional teams·        Ability to work independently and proactively within a fast-moving, dynamic environment·        Effective verbal communications; comfortable in a client-facing role

Qualifications: ·        BS or higher in a relevant scientific discipline·        Minimum 5 yrs of experience in a regulatory support role·        Prior experience in a quality or manufacturing role involving FDA regulated products Salary range $85,000 - $125,000/year depending on experience