Our client is a biopharmaceutical company located in the Princeton, NJ area. With strong financials, a marketed product and promising pipeline, over 50 patents, and proprietary, patented platform technology this company has a strong foundation to continue to build upon. The correct individual for this role will thrive in a fast paced culture where you are free to lead. Someone who can make an immediate, lasting impact on the organization.
- Acts as the Company’s representative and primary contact relative to regulatory affairs.
- Will manage and facilitate information flow and interactions between external consultants, manufacturers and CRO’s with the Company’s product development, quality assurance/control, regulatory, clinical and manufacturing departments to ensure compliance and coordinate the successful execution of the Company’s regulatory affairs strategies.
- Directs the Company’s regulatory affairs function by implementing strategies developed in coordination with senior management and regulatory consultants. Responsible for managing regulatory filings for phase 1 clinical trials through phase 4 applications and filings for marketed products (annual reports, major supplements, annual safety updates).
- Will act as the Company’s primary contact with FDA.
- keeps abreast of regulatory (FDA/European/ICH) guidelines
- analyzes and evaluates the impact of trends relative to government regulatory activities
- provides consultation for Company projects, recommends and implements strategies to affect the earliest possible approval of regulatory filings, responses and documents
- develops proposals, recommendations and presentations relative to the identification and implementation of the Company’s regulatory strategies as they relate to corporate strategies and objectives.
- Supervises regulatory affairs staff, including regulatory consultants. Oversees and participates in the preparation of regulatory document packages (meeting requests and briefing packages, IND, NDA and BLA) and responses to regulatory agencies including preparing and reviewing scientific technical documents for regulatory adequacy and compliance to ensure timely preparation and submission of documents, responses and filings.
- Develops budgets and monitors expenditures for internal and external resources for the regulatory affairs function.
- Bachelor’s Degree
- Regulatory Affairs Society (RAPS) certification and/or Master’s degree in related discipline preferred
- 10+ years pharmaceutical quality assurance and regulatory affairs (GCP & CMC) experience
- 5+ years management experience in regulatory affairs with a biotechnology or pharmaceutical organization
- Sound working knowledge of regulatory requirements (e.g. FDA/ICH, GCP, GMP Regulations) and experience with submissions (IND, NDA/BLA) and regulatory responses
- Computer literate; MS Office Suite (Word, Excel, Power Point), Outlook