Sr. Mgr. of Regulatory Affairs

General Accountabilities:

·                       Act as the Regulatory Affairs Representative on Project Teams.

·                       Work with management and Project Team members to develop strategies and advice for addressing the issues for developmental and marked products.

·                       Represent the company during interactions with regulatory agencies. Makes arrangements for regulatory agency meetings (face-to face and teleconferences).

·                       Prepares records of regulatory agency transactions.

·                       Prepare or manage the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies.

·                       Schedule, coordinate, prepare and review Investigational Applications (original submissions and amendments) and Market Applications (original submissions and supplements) in cooperation with the Project Team members.

·                       As assigned, review advertising and promotion pieces.

·                       Maintain an intimate knowledge of regulations, particularly for biologics, including proposed and final rules; assure that awareness of these regulations exists within the department.

·                       Maintain an intimate knowledge of corporate policies and procedures as they relate to developmental and marketed products.

·                       Monitor current and proposed regulatory and legal issues through external meetings, workshops and the Internet.

·                       Author and maintain Standard Operating Procedures and Local Working Practices as assigned.

·                       Handle non-project related projects as assigned.

Qualifications:

Training and Experience:

·                       BS / BA in life science or advanced degrees.

·                       Regulatory experience 6 to 8 years with 7 to 10 years of pharmaceutical or related experience.

·                       Good understanding of regulations, guidelines and scientific principles.

·                       Provides recommendations to supervisor and managers a project and/or staff with minimal supervision.

·                       Management experience working with both projects and staff.

·                       Must have exceptional organizational skills and knowledge of FDA regulatory requirements and ICH guidance.

·                       Interpersonal, administrative, written and verbal skills required.

·                       Requires a self-starter with the ability to work on his/her own as well as define, coordinate and direct assignments to project team members.