Allergan Dir, Sr Regulatory Affairs Advertising & Promotion in Jersey City, New Jersey
Dir, Sr Regulatory Affairs Advertising & Promotion
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/791/other-jobs-matching/location-only
▾ ▸ 1 additional location
Irvine, California, United States
Oct 05, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Oursuccess is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Join our bold team! Learn more at www.Allergan.com at http://www.allergan.com/ .
The role of the Sr. Director is to serve as the primary Drug Regulatory Affairs representative on assigned Allergan product promotion review teams with the responsibility of reviewing and approving regulatory content of product promotion and communication materials, including sales training materials. Serve as a primary liaison with FDA (OPDP) on regulatory issues concerning promotional materials.
Main Areas of Responsibilities
Provide regulatory leadership to the respective cross-functional team charged with advertising and promotion review to ensure compliance of promotional materials, including but not limited to Physician and patient sales Marketing and educational materials, Training materials, Slide presentations, Press releases and external communications with FDA regulations and company policies.
Attend promotional review meetings, review all promotional materials, and provide comments in accordance with marketing timelines and FDA regulations.
Develop and maintain relationships with other internal departments involved in the product promotion and communication process.
Develop DRA best practices, working instructions, SOPs for product promotional activities, to establish standards and consistency across company brands.
Review and approve 2253 submissions to OPDP related to assigned products. Provide guidance and support to Drug Regulatory Affairs regarding 2253 submission activities.
Advise product development teams on advertising and promotion issues to facilitate the strategic development of new products (e.g., providing input in the creation of draft labeling).
Maintain regulatory expertise in product promotion compliance by keeping current with issued FDA (OPDP) Warning and Untitled letters and attendance at product promotion seminars / workshops.
Communicate new regulatory standards pertaining to prescription drug promotion and advertising to brand teams and management, as appropriate.
Provide guidance / training / support within Allergan regarding regulatory requirements for prescription drug promotion and advertising.
Identify and escalate any unresolved regulatory affairs compliance concerns to the Exec. Director, Ad Promo and Labeling, Regulatory Affairs.
Bachelor’s degree (technical/scientific background, biology/chemistry is a plus)
Minimum 7 years pharmaceutical industry experience required.
5 years’ experience in the regulatory review of product promotion and communication materials, or related activities.
Experience communicating and interacting with the FDA/Health Authorities.
Proficient knowledge of (1) prescription drug advertising and promotion regulations, (2) FDA (OPDP) organization, and (3) regulatory compliance and applicable 21 CFR regulations
Strong knowledge of drug development, including clinical and post-marketing stages with a focus on the generation of clinical data to support marketing communications
Strong technical background including proficiency in Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Adobe Acrobat