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Associate Director Regulatory Affairs

Company: Novartis Group
Location: Princeton
Posted on: April 8, 2021

Job Description:

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
Job Description
The Associate Director of Regulatory Advertising and Promotion is responsible for strategic leadership of regulatory reviews and guidance relating to promotional activities for assigned products.
--- Serves as a regulatory reviewer for assigned products. Ensures regulatory compliance while effectively managing business risks.
--- Directs the activities of regulatory personnel responsible for submissions of promotional materials to FDA.
--- Ensures that strategic regulatory subject matter expertise is provided on advertising and promotion materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
--- Reviews relevant medical and clinical development non-promotional materials in accordance with company policies.
--- Engages in training/mentoring of new hires and junior colleagues in the Regulatory Ad Promo group.
--- Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products, including authoring responses to OPDP letters and complaint letters to OPDP.
--- Maintains awareness of driven activities by monitoring at major US Medical meetings.
--- Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate).
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements
--- BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD)
--- Minimum 7 years regulatory experience preferred
--- Biologics experience is highly preferred
--- Excellent understanding of US regulations for drug promotion/advertising and US labeling.
--- Experience in the regulatory review of professional and consumer Rx drug advertising and promotion.
--- Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.

Keywords: Novartis Group, Trenton , Associate Director Regulatory Affairs, Executive , Princeton, New Jersey

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