Pharmaceutical Director Regulatory Affairs

Pharmaceutical: Director, Regulatory Affairs

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Location:  Eastern PA; no relocation
Compensation:  $170 - $180 Base +

Our client is a fast paced, fast growing pharmaceutical company. We are seeking high energy individuals who are ready for this exciting opportunity and the chance to further establish your career. If you have current pharmaceutical Regulatory Affairs experience, as well as women’s healthcare, this may be the next best step for you! We are looking for dynamic leaders who want to work in a cutting edge environment and want to create impact in a company working to make a difference. For immediate and confidential consideration, please send a Word version of your resume and note the site you saw the posting.

Summary

Reporting to the VP of Regulatory, the Director will develop, coordinate and execute domestic and global clinical regulatory strategies for Women’s Health products for new products as well as line extensions or new indications for marketed products. This individual will interact with global regulatory counterparts on the development of ex-US clinical submission strategies and provide support as needed.  Also, he/she will interact with FDA and ex-US health authorities as needed, oversee maintenance activities for marketed products, and support in-licensing opportunities.
 
Duties and Responsibilities

• Lead proprietary development teams in the development and execution of clinical strategies for regulatory submissions at all phases of development (e.g, NDAs, sNDAs, INDs, MAAs, and BLAs). 

• Products include oral contraceptives, hormone therapy products, IUS, and other novel delivery systems. 

• Proactively identify potential clinical issues and develop approaches to address them. Interface with the FDA regarding non-clinical and clinical development issues and provide support to ex-US Regulatory counterparts regarding non-clinical and clinical support, including the preparation of technical position papers, as needed.

• Coordinate the preparation of clinical and non-clinical sections of CTAs, INDs, NDAs, sNDAs, BLAs, including liaising with US and ex-US regulatory personnel as required. 

• Conduct gap analyses in a timely manner. 

• Oversee the maintenance of these documents in CTD format. Represent the TWH RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.

• Oversee labeling/packaging component revisions and implementation of label changes. Ensure development and submission of appropriate prescribing information.

• Provide support for review and regulatory approval of promotional materials for Rx and OTC products.

• Coach and mentor staff in the performance of their duties. 

• Identify opportunities for enhanced efficiency of departmental activities. 

• Liaise with other functional areas such as Medical Affairs, Clinical Operations and Marketing.  

Requirements

• PhD in a scientific discipline with 4-8 years experience in Regulatory Affairs; or MS / PharmD with 6-10 years Regulatory Affairs experience; or B.S. with 8-12 years Regulatory Affairs experience required.

• Minimum of 4-8 current years in Regulatory Affairs required. Prior experience in Women’s Health required.

• Prior experience in pharmaceutical development and/or clinical development a plus.

• In-depth knowledge of FDA regulations regarding pre-clinical and clinical requirements.

• Experienced with DDMAC requirements; knowledge of OTC requirements desirable. Experience with IND, NDA and/or BLA filings.

• Experience with eCTD documentation a definite plus, as is experience within a controlled documentation system.