Regeneron Pharmaceuticals, Inc.
Tarrytown, NY, United States
Advertising, Marketing, Pharmaceutical
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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
This position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances 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’s objectives, while maintaining the necessary state of compliance and corporate integrity.
• Management of US and Global regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Provide regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Review and approve US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
• Assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including pre-clearance of materials.
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
• 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 the company policies.
• Provide input to key stakeholders with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
• Cross train across products to ensure continuous Regulatory A&P support is provided to stakeholders
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
• Provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.
• Requires advanced scientific degree (i.e., Masters, PharmD) with a minimum of 3-5 years within regulatory affairs, reviewing promotional materials and interacting with OPDP/APLB and managing launch campaigns
• Expert knowledge of 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 working with the FDA, specifically OPDP/APLB
• Must possess excellent written/verbal communication skills
• Proven ability to influence cross-functional teams and work effectively with senior management
• Familiarity with labeling regulations
• Experience with global promotion review and clinical trial recruitment materials is a plus
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 Regeneron’s 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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Regeneron Pharmaceuticals, Inc.
Website : http://www.regeneron.com/
Our first approved product, ARCALYST® (rilonacept), an anti-inflammatory agent, has been available to patients in the U.S. since 2008. In late 2011, we launched EYLEA® (aflibercept) Injection, also known in the scientific literature as VEGF Trap-Eye and Intravitreal Aflibercept Injection, and received approval from the FDA for a second indication in September 2012. In August 2012, Regeneron and Sanofi, obtained FDA approval for ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion.