Director, US Regulatory Advertising & Promotion; Remote

## Director, US Regulatory Advertising & Promotion (Remote)
Apply locations:
Cambridge (US) time type:
Full time posted on:
Posted Todayjob requisition :
R-22161
*
* Title:

** Director, US Regulatory Advertising & Promotion (Remote)
** Company:
** Ipsen Biopharmaceuticals Inc.
** About Ipsen:
** Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.

We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at
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*
* Job Description:

**** The Director, Commercial Regulatory Affairs will report to the Sr. Director and have accountability for review and approval of promotional and medical communications of assigned brand(s). The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The incumbent’s responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively.

Medical communications will be reviewed and approved at MRC in a similar process to PRC. This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations and Business Ethics for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and Ipsen policies.
**** WHAT -*
* ** Main Responsibilities & Technical Competencies**
* ** Serve as the internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations.**
* ** Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy and leadership on assigned Promotional Review Committee(s) (PRC) with respect to best practices in compliance with company policies and guidelines for PRC processes. Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid, and appropriate.**
* ** Develop SOPs and work instructions to facilitate stream-lined workflows and encourage proficient practice of process policy.**
* ** Liaise with OPDP/FDA as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials. Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff.**
* ** Foster a business partnership environment grounded in…