Regulatory Affairs Specialist

Great opportunity to be part of a dedicated team serving the rapidly expanding Cell and Gene therapy market. Vector Biomed is a leading supplier of high-quality Lentiviral vectors for research and clinical use. We are seeking an exceptional team member to provide regulatory and product development support in a dynamic small company setting. If you are comfortable on the cutting edge and passionate about supporting the clinical development and commercialization of advanced therapies, you’ll fit right in at Vector BioMed.

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