Director, Promotional Regulatory Affairs

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Director, Promotional Regulatory Affairs is responsible for providing regulatory review of advertising and promotional materials, and other Commercial and Medical Affairs communications, in order to ensure compliance with company policies, FDA regulations and guidelines, and other Health Agency regulations. The position also provides strategic and operational regulatory leadership concerning advertising and promotional issues to assigned project teams.

Essential Functions of the Job (Key responsibilities)
Works closely with representatives from Marketing, Legal, and Medical Affairs in the development of advertising and promotional materials.
Ensures compliance with applicable FDA and state regulations and those of other Regulatory Agencies.
Provides input into labeling, company-sponsored educational seminars, content of displays at major meetings, responses to physician inquiries, and other communications.
Ensures advertising and promotional materials are updated to be consistent with current labeling.
Delivers regulatory compliance training to members of cross-functional teams as needed.
Participates in the development of commercial compliance policies to support the commercial interests of the business.
Serves as point of contact with the FDA Office of Prescription Drug Promotion (OPDP) and directs the timely submission of all applicable approved promotional materials to the FDA and to other Regulatory Agencies, as required.
Manages the maintenance of records and databases that support communication with OPDP and other Regulatory Agencies.
Maintains awareness of the promotional regulatory environment with the FDA and understands international/global promotional issues.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS or Ph.D., PharmD in a scientific discipline or equivalent experience.
Minimum of 5 years' experience in pharmaceutical industry that includes direct experience in promotion and advertising and commercial compliance in a high growth, fast-paced pharmaceutical environment.
Direct experience as liaison with OPDP.
Broad knowledge of Labeling, Advertising and other applicable regulations.
Knowledgeable in both State and Federal requirements regarding commercial compliance in advertising and promotion.
Experience in oncology/accelerated approval promotion would be advantageous.
Knowledge and experience of European/International requirements for promotion of ethical pharmaceuticals would be advantageous.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

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Job Posting: 997421

Posted On: Jul 02, 2022

Updated On: Jul 27, 2022