Director, Commercial Regulatory Affairs

Title:

Director, Commercial Regulatory Affairs

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Director, Commercial Regulatory Affairs

Position Summary

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.

Commercial regulatory is a solid partner with internal stakeholders providing proficient advice and practical solutions resulting in compliant communications about our products and disease areas of focus.  As our portfolio expands so does our team. There is great opportunity for growth. Ipsen has global goal to fill 65% of leadership roles through internal promotion and has been named Best place to work in 75% of countries in which we operate. Ipsen culture is driven by desire to collaborate and excel for the benefits of patients and society. Our Ipsen Way of Being is a crucial success driver for our strategy and our colleagues are the hearts, brains and architects of Ipsen’s success, now and in the future.

Essential Functions

Responsibilities

Responsibilities will include, but are not limited to, the following:

• 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 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 management of tasks that help support compliant execution of Marketing tactics and programs: implementing revised product labels in promotional materials, establishing life-cycle of content, appropriate balance and risk information and requisite training materials for reps

Qualifications

Education

• Minimum BS in scientific discipline
• Advanced scientific degree preferred, JD, MBA

Experience

• Minimum of 10 years of experience in pharmaceutical industry and a minimum of 3-6 years in commercial regulatory affairs
• Experience in Rare Diseases, Neuroscience and/or Oncology a plus 
• Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
• Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters
• Oversee OPDP submissions and author all submissions for assigned products

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

• 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 with 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
• 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

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.