Vice President, Regulatory Affairs
Job Title: Vice President, Regulatory Affairs
Location: Raleigh, NC
Reports To: Executive Vice President, Product Development
Education: PhD, RAC
A minimum of 5 years of industry-related experience in regulatory affairs
This position has responsibility for all aspects of regulatory affairs and compliance including strategy.
Responsible for development and execution of the company’s regulatory strategy
Manage regulatory affairs and compliance staff, contracts and all regulatory affairs activities including the preparation and maintenance of clinical trial and marketing applications, and the regulatory archive.
Create and maintain company policies and procedures detailing regulatory processes.
Keep abreast of changes in the regulatory environment impacting the company’s operations, interpret impact, and plan accordingly
Ensure that all clinical, nonclinical, and chemistry submission documents are reviewed for regulatory suitability and compliance.
Lead all communications with the United States Food and Drug Administration and other regulatory authorities.
Maintain a high profile in the regulatory community.
Duties as may be assigned.