Job Description
SUMMARY
The Associate Director, Regulatory Affairs Advertising and Promotion will be responsible for applying clinical development knowledge in concert with expert understanding of international (markets ex-US) advertising and promotion regulations/guidelines to the development of key product messages presented in Marketing Authorization Applications (MAAs). Provide expertise to relevant collaborators, typically carrying out the responsibilities with minimal mentorship from the Director. Supervise therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the vital state of compliance and corporate integrity.
JOB DUTIES:
Management of Global regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. Leads commercial activities from a regulatory advertising and promotion perspective independently.
Act as the regulatory reviewer to ensure specified materials and activities linked to promotion meet external regulations, industry code of practice standards (EFPIA/IFPMA) and Company policies.
Serve as the primary liaison for the final signatories of materials at company affiliates to promote best practices and provide support on regulatory issues concerning promotional materials.
Creatively advise on product messages and materials across multiple functional areas.
Independently provide timely regulatory advice and mentorship to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Independently provide review of Global product and disease state materials/communications to support goals and align with applicable laws, regulations, and guidance.
Collaborate cross functionally with key team members in areas such as Marketing, Medical Affairs, and Legal.
JOB REQUIREMENTS:
Knowledge of international regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
Experience with pharmaceutical products required, biologics experience is a plus
Experience in reviewing promotional materials and handling launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
Experience in global promotional review and clinical trial recruitment materials
Proven track record to lead and influence cross-functional teams and work optimally with senior management
To be considered, we expect you to have 5-7 years of Regulatory Advertising & Promotion experience along with a scientific degree. It is helpful to have a MS, PharmD, PhD but Bachelors is a minimum requirement
Familiarity with labeling regulations is helpful
English language is required
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.