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Senior Director, US Commercial Regulatory Affairs

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge
Start date
Jun 12, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Pharm Country

Job Details

Title:

Senior Director, US Commercial Regulatory Affairs

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Head, US Regulatory Advertising, Promotion and Labeling

Summary / purpose of the position

The Head, US Regulatory Advertising, Promotion and Labeling is responsible for post-marketing regulatory activities to support Ipsen’s marketed products in the US and for leading the team involved in such activities including prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as required, working with Global Regulatory Labeling to review and assess forth coming changes. The incumbent will establish collaborative partnerships with key stakeholders to ensure successful and compliant activities and deliverables; train and guide the company on regulatory expectations and requirements. This individual is responsible for managing and evolving the Promotional Review Committee process to ensure that the business needs are met efficiently and effectively. This position is essential in building and maintaining a best- in -class US framework of compliance with applicable FDA regulations and company policies for the advertising, promotion and labeling of prescription drugs and biologics.

Finally, this role works with cross-functional areas to determine the appropriate strategy for labels for regulatory authority review and approval and, after approval, for maintaining labeling documents (implementing into packaging, promotion and posting on DailyMed).

Main responsibilities / job expectations

  • Responsible for the review, approval, and submission of US promotional materials
  • Lead and foster Ipsen’s relationship with the FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Liaise with FDA as needed on promotional issues. Serve as the internal subject matter expert on FDA Advertising & Promotion issues and provide internal training as needed on FDA requirements.
  • Develops and leads departmental strategic initiatives. Serves as resource to internal leadership on regulatory and risk assessment for new commercial initiatives.
  • Engages in appropriate activities to improve the regulatory environment through Agency Contacts: OPDP, APLB, and associations as appropriate.
  • Enhances collaboration across the organization while developing and maintaining varied disciplines across multiple review committees.
  • Provides mentoring and promotional regulatory training to the organization and team members.
    • Responsible for the Promotional Review Committee (PRC) Process and compliance with FDA advertising and promotional regulations, including 2253 submissions and subpart H preclearance requirements.
    • Foster a business partnership environment between Regulatory and PRC partner functions in the review and approval of Ipsen advertising and promotional materials.
    • Develop SOPs or working instructions to ensure consistent high quality regulatory affairs function and efficient promotional review process.
  • Partner with Global Regulatory Strategy and Labeling on future/planned labeling updates to communicate US requirements and expectations. Assess impact to current advertising and promotion materials.
    • Partner with Regulatory Operations on the development of Structured Product Labeling (SPL), including Establishment and Drug Listings, and implementation of labeling into packaging, promotion, and posting on DailyMed for all marketed products.
  • Ensure Ipsen is launch-ready and regulatory is appropriately resources to ensure success.

Knowledge, abilities & experience

Education / Certifications:

  • Minimum master’s degree in life sciences

Experience:

  • Minimum of 12 years’ experience working in a regulated life science environment (pharmaceutical, biotechnology); 7 years or more experience working within promotional regulatory affairs; 3 years of more experience in people management.
  • Advanced working knowledge of Advertising, Promotion and Labeling regulations, guidance and OPDP expectations.
  • Advanced experience providing regulatory input and evaluation as part of a promotional review committee.
  • Extensive experience of submission requirements for accelerated approval applications
  • Significant track record in leading staff in development of advertising, promotion and labeling materials in preparation for US commercial launch.
  • Superior communications skills: oral, written, negotiation skills, and strong time management. Confident in interactions with commercial and medical affairs leaders.
  • Collaborative and solution-oriented mindset and approach.
  • Strong strategic and analytical thinking and decision-making skills.
  • Experience working with external consultants and contractors.
  • Experience working within rare diseases, neurology, oncology a plus.

Languages:

  • English. French is a plus.

Key Technical Competencies Required

  • Experience in working with Veeva PromoMats, Microsoft Office

The annual base salary range for this position is $215,250-$315,700.

This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

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.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
US

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