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Assoc. Director/Director, Regulatory Affairs, Advertising & Prom

Company Name:
Regeneron
Job Description:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary:
This position within the Regulatory Affairs department involves the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulation/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Will ensure that messages are translated into advertising and promotion initiatives that meet the commercial team objectives while maintaining the necessary state of compliance and corporate integrity.
Responsibilities:
Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
o Provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
o Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising
Management of all regulatory activities associated with commercial development of pipeline products as well as advertising and promotion of Regeneron marketed products
o Regulatory representative on Regeneron review committees providing scientific/evidence based guidance and regulatory input with respect to all types of promotional activities and clinical trial recruitment materials
o Liaison responsible for establishing working relationship and managing communication with FDA OPDP reviewers with respect to advertising and promotion matters including pre-clearance of materials
o Responsible for compliance with promotional material submissions to FDA
o Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
o Provide regulatory advice and guidance to commercial teams and Medical Affairs department with respect to conference exhibit activities and speaker programs
Management of information exchange with key stakeholders contributing to advertising and promotion activities
o Continually monitor newly published FDA guidelines and regulation (including international guidance documents) in the context of impact to promotional standards and policy
o Provide training on applicable requirements for promotional activities to commercial, regulatory and medical staff as required
o Provide promotional regulatory compliance training to field personnel and company attendees in conjunction with commercial presence at medical conferences
o Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on Regeneron policies.
o Provide input to key stakeholders with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
Experience and Required Skills:
Qualified Candidates should have an advanced degree in a science related discipline with a minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include direct regulatory promotion and advertising experience. Experience with clinical development of biotechnology products highly desirable. Must possess excellent written and verbal communication skills.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Apply Online:
http://careers.regeneron.com/united-states/clinical-data-management/jobid5138564-assoc.-director_director-regulatory-affairs-advertising-%EF%B9%A0amp;-promotion-jobs
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