Senior Specialist, Regulatory Affairs

Job Description

The Senior Specialist is responsible for the review and approval of US promotional materials.

As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company policies, and support business objectives

Under the direction of a Team Leader or Mentor: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments. Conduct regulatory risk analysis and identify regulatory issues.

Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate (written and verbal) basic regulatory positions.

Contribute to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices.

Qualifications, Skills & Experience:

Minimum Requirement:

B.A. or B.S. degree with an emphasis in science, health care or related fields.