Job title: Manager, Regulatory Affairs

Reports to: Vice President, Regulatory & Corporate Compliance

SUMMARY
Preparation, review and submission of various Controlled Documents to the Food and Drug Administration (FDA). The approval by the FDA of the submissions will allow the company to market new products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Developments content and format for regulatory submissions, such as ANDAs and their related supplements and amendments.

· Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.

· Negotiates directly with regulatory authorities regarding company’s filings.

· Preparation of Annual Reports to ANDAs for submission to the FDA.

· Preparation of Adverse Drug Events Reports for submission to the FDA.

· Preparation and/or review of documents for inclusion within the above referenced submissions.

· Preparation of submissions for FDA’s National Drug Code (NDC) Listing.

· Preparation and submission of documents to three (3) State Formularies.

· Reviews regulatory publications to keep apprised of new regulatory developments.

· Developments content and format for regulatory submissions, such as ANDAs and their related supplements and amendments.

· Reviews and approves regulatory submissions, such as ANDAs, NDAs, etc.

SUPERVISORY RESPONSIBILITIES (DIRECT SUBORDINATES):

- Supervisor, Safety Management
- Regulatory Affairs Senior Associate
- Regulatory Affairs Associate
- Technical Affairs Specialist
- Document Control Associate

David Jacks
ExecuSource
244 Fifth Avenue #2205
New York, NY 10001
Direct: 646-438-9244

E-mail