Director, US Regulatory Advertising & Promotion (Remote)

Ipsen•Cambridge, MA

4d•$177,000 - $260,000•Remote

About The Position

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of development experience and global hubs in the U.S., France, and the U.K., Ipsen tackles areas of high unmet medical need through research and innovation. Their passionate teams in over 40 countries are dedicated to bringing medicines to patients in 88 countries. Ipsen fosters a human-centric leadership and a culture of collaboration, excellence, and impact, empowering individuals to be their true selves, grow, and thrive. The company is committed to sustainable growth and creating real impact on patients and society. The Director, Commercial Regulatory Affairs will report to the Sr. Director and be responsible for the review and approval of promotional and medical communications for assigned brand(s). This role involves leading interactions with the FDA Office of Product and Drug Promotion (OPDP) concerning assigned brands and managing all submission types to OPDP/FDA. The Director will lead review meetings to ensure compliance with and evolution of the Promotional Review Committee (PRC) process, enabling efficient and effective business needs. Medical communications will undergo a similar review and approval process through the Medical Review Committee (MRC). 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 to provide regulatory advice and guidance throughout the promotional plan development and field implementation, ensuring conformity with FDA requirements, PhRMA DTC Guidelines, and Ipsen policies.

Requirements

Minimum of 8 years’ experience in the pharmaceutical industry.
Minimum of 6 years in regulatory affairs.
Expert knowledge of advertising promotion regulations and FDA Guidance documents.
Technical experience in aspects of drug development and labeling.
Solid experience with promotional and medical review supporting product communications.
Experience working with FDA (OPDP, APLB) on advertising and promotion matters.
Ability to oversee OPDP submissions and author all submissions for assigned products.
Ability to understand and interpret clinical trial data.
Expert understanding of FDA promotional regulations, product, and therapeutic knowledge, as well as evidentiary standards required to support product claims.
Excellent oral and written communication and negotiation skills.
Strong attention to detail.
Seasoned ability to spot issues and convey unique product facts, offering ideas and options as guidance to mitigate risks.
Ability to articulate the impact to Ipsen associated with insufficient mitigation of risks.
Ability to influence and interact effectively across relevant functions within Ipsen and with regulators.
Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards.
Must be an innovator of new ideas and best practices.
Must anticipate and solve problems.
Recognized as a leader, team player, and possess a cross-functional collaborative skill set.
Ability to manage multiple activities or projects.
Bachelors degree in a scientific discipline.
Fluent in English.

Nice To Haves

Experience in Rare Diseases, Neuroscience and/or Oncology.
French language proficiency.

Responsibilities

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 on FDA requirements, PhRMA DTC Guidelines, and Company policy, and provide leadership on assigned Promotional Review Committees (PRC) regarding best practices in compliance with company policies and guidelines for PRC processes.
Demonstrate leadership as the regulatory reviewer on copy approval teams, ensuring recommendations are well-reasoned, valid, and appropriate.
Develop SOPs and work instructions to facilitate streamlined workflows and encourage proficient practice of process policy.
Liaise with OPDP/FDA as needed for assigned product(s), serving as the company's single point of contact with FDA on matters related to advertising and promotional materials.
Manage interactions with OPDP/APLB, including responding to regulatory inquiries, preparing complete, accurate, high-quality submissions for advisory comments, and discussing with OPDP/APLB staff as needed.
Foster a business partnership environment grounded in trust and transparency between Regulatory and PRC partner functions in the review and approval of Ipsen product communications.
Collaborate with partner functions to share commercial regulatory guidance on US Commercial Teams’ strategic imperatives.
Lead PRC teams in managing tasks that support compliant execution of Marketing tactics and programs, including implementing revised product labels in promotional materials, establishing content life-cycles, ensuring appropriate balance and risk information, and developing requisite training materials for representatives.