Convenes GRS leadership team assuring the establishment and maintenance of a collaborative performance-oriented culture.
Owns global resource allocation to projects and product teams.
Participates in the development of global strategies and translates those into region and possibly site-specific deliverables.
Responsible for global regulatory project/product governance and governance processes.
Engages in activities to influence the regulatory environment.
Ensures development of all GRS staff to help them achieve their full potential.
Requirements
Bachelor’s degree with 15+ years, OR Master’s degree with 13+ years, OR PhD/PharmD/MD with 10+ years' experience in drug development/commercialization.
Minimum of 10 years’ experience in an industry regulatory affairs function and/or a major regulatory agency.
Proven examples of drug development experience or other relevant experience within the pharmaceutical industry/FDA/EMA.
Proven track record of successful management of staff and complex regulatory issues.
Regulatory experience with drugs across life cycle, FDA Advisory Committee and other major Health Agencies’ hearings.
Strong logical and analytical skills.
Excellent communication skills.
Benefits
Health benefits to include medical, prescription drug, dental and vision coverage.