Senior Product Manager, Regulatory Affairs

Under the direction of the Director, Regulatory Support & Liaison, the incumbent is responsible for defining worldwide regulatory requirements for specific segments of a project or a specific entire project, as assigned, related to the management of approved products. The incumbent is expected to maintain an up-to-date knowledge of US and Canadian regulations and guidelines and to be able to recommend regulatory strategy or action that protects company interest and ensures product compliance.


?Define strategic registration plans and regulatory strategy for assigned site transfers projects. Coordinate activities, define timing and prepare submissions related to the approved product management.
?Serve as a liaison with FDA for assigned projects.
?Review, categorization and submission of promotional literature to FDA.
?Review and ensure proper implementation of State Regulations.
?Assist in the evaluation of manufacturing and business change requests as appropriate.
?Maintains an awareness of current regulatory environment and current developments in assigned areas. Participate in trade associations? activities as assigned.

 

Bachelors Degree and 10 years or a Masters Degree and 8 years of regulatory experience in the pharmaceutical industry. Record of achievement of regulatory approvals and demonstrated success dealing with regulatory authorities. Demonstrated interpersonal and communication skills, initiative and independent judgment are required.

 

EOE/AA/M/F/D/V