Associate Director, Regulatory Affairs

. Responsibilities: - Ensures that CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual countries.
-Takes a leadership position in conducting risk assessments on major global CMC regulatory issues, and providing guidance to corporate management.
- Plays a leadership role on project and other teams in developing global CMC regulatory and change control policies and strategies.
- Must work proactively to build contacts with local Health Authorities, and to present a positive image of Gilead in all discussions with Health Authorities.
- Will be responsible for ensuring timely discussion with Health Authorities regarding responses to questions, and will work with international colleagues to ensure consistency of responses to international Health Authorities.
- Will take a leadership role in working with senior management to assess the impact of major international CMC regulatory guidance on the corporation. Will be expected to use industry network to maintain an awareness of the 'pulse' of CMC best practices, and to disseminate this information to the corporation.
- Will be expected to pro-actively form ad hoc task forces to address critical CMC issues, and will be expected to provide leadership to project and department teams.
- The incumbent should play an active role in organizations such as PhRMA, EFPIA, DIA, AAPS, PDA, etc., through participation in planning committees or giving presentations on significant CMC Regulatory issues.

Requirements:

-B.S., M.S., Ph.D, degree, Chemistry, Biology, or Pharmacy background is preferred.
-Minimum 12 years of regulatory affairs experience is required.
-Must be well versed in global CMC, and have a proven track record of successful resolution of complex global CMC issues.
-Direct and extensive experience working with Health Authority chemistry reviewers is a must.
-Must have considerable negotiation skills, and must be able to communicate verbally and orally with a very high level of proficiency.
-Experience representing regulatory affairs on project teams is essential.
-Must have a proven track record of conducting CMC risk assessment.
-Must have a demonstrable track record of successful negotiation of complex regulatory strategies Health Authorities.
-The incumbent must have a thorough understanding of ICH and regional CMC guidance, must have an astute understanding of current trends in CMC regulatory affairs, and must be capable of assessing and articulating this knowledge to corporate customers.
-The successful incumbent will have a broad understanding of pharmaceutical manufacturing, change control, and distribution systems in the EU, US, and other applicable territories.

RESPOND HERE! Respond immediately by accessing the following
dedicated online response form which will allow you to cut and paste your
resume. This form will go directly and immediately to the
hiring authority for this position. Access the online response form at: