Senior Director, US Commercial Regulatory Affairs Specialist
3 weeks ago
The Senior Director, US Commercial Regulatory Affairs is responsible for leading the team involved in post-marketing regulatory activities to support Ipsen's marketed products in the US. This includes prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as required, working with Global Regulatory Labeling to review and assess forthcoming 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.
Main Responsibilities
- 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.
Key Requirements
- Minimum master's degree in life sciences
- 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.
Technical Competencies
- Experience in working with Veeva PromoMats, Microsoft Office
Benefits
- 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.
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Cambridge, Massachusetts, United States Ipsen Pharma Full timeJob SummaryThe Senior Director, US Commercial Regulatory Affairs will lead the development and implementation of regulatory strategies to support Ipsen's commercial operations in the US. This role will be responsible for ensuring compliance with FDA regulations and guidelines, as well as maintaining strong relationships with key stakeholders.Key...
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