Regulatory Affairs Manager

Position Details: 

Client Direct Client

Location Wayne, PA

Job Title Regulatory Affairs Manager

Duration 6 Months+

Must have skill-set [Job Description] Job Summary:

Responsible for the management and conduct of US regional regulatory activities as directed by and under supervision of manager. Lead regulatory activities for assigned projects in line with US regulatory requirements.

Primary Responsibilities Include: 

•With supervision as appropriate, function as liaison between FDA and company for assigned projects. 

•The planning, coordination, organization and preparation of complete high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. 

•Ensuring regulatory compliance for all assigned responsibilites. 

•Responsible for the implemention of regulatory strategies for the development and maintenance of assigned product or products. 

•Maintain up-to-date knowledge and expertise of FDA regulations/guidance documents, and ICH guidelines 

Responsibilities: 

- Prepare, compile, review/qualilty control and process regulatory submissions including INDs, BLA, NDA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc. 

- Attend and participate in assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations. 

- Coordinate and consult with other departments on the content, quality and assembly of regulatory documentation. Ensure consistency, completeness and adherece to standards for all regulatory submissions. 

- Conduct regulatory communications with FDA, under appropriate supervision and direction, for assigned products and activities. 

- Coordinate FDA meeting requests, meeting rehearsals, briefing book preparations and preparing meeting minutes of FDA meetings.