Senior Director, Regulatory Affairs – Advertising & Promotion
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Job Description
Senior Director guiding FDA promotional compliance for Summit Therapeutics, a biopharmaceutical oncology company. Reviewing promotional materials, leading regulatory strategy, and coordinating with FDA and cross-functional stakeholders.
Responsibilities:
- Evaluate Commercial, Legal/Compliance, and Medical perspectives and provide expert regulatory guidance on promotional, disease state education, corporate, and other non-promotional materials
- Review materials in Veeva and participate in Medical Review Committee and Promotional Review Committee meetings
- Review and interpret enforcement actions and FDA Guidance to Industry documents
- Contribute to internal MRC/PRC processes ensuring materials comply with FDA regulations
- Provide guidance on process enhancements, compliance, and process efficiencies
- Develop and implement regulatory advertising and promotion strategy and manage complex negotiations
- Guide communications with healthcare professionals, patients/consumers, payers, executive management, and other audiences
- Facilitate submission of branded promotional materials to FDA on Form 2253
- Act as the main point of contact with FDA's Office of Prescription Drug Promotion
- Advise management and cross-functional teams on relevant laws, regulations, guidelines, and standards
- Ensure corporate goals are met for assigned projects
- Represent Regulatory Affairs independently under direction of the Vice President of Regulatory Affairs
- Potentially manage direct reports and contribute to performance management for other Regulatory Affairs team members
- Participate in professional associations, industry, and trade groups as appropriate
- Follow budget allocations
Requirements:
- Bachelor's degree in a scientific discipline and 12+ years of related experience, or equivalent combination of education and experience
- Advanced degree (MS, PharmD) preferred
- Strong Regulatory Advertising and Promotion knowledge
- Demonstrated success preparing and submitting regulatory documents
- Strong understanding of Advertising and Promotion and regulatory requirements for prescription-drug promotion
- Experienced user of the Veeva ecosystem for Promotional Review Committee-related items
- Strong communication and proactive negotiation skills
- Ability to communicate effectively and articulate complex ideas clearly
- Ability to work successfully in a fast-paced, demanding, and collaborative environment
- Willingness to travel up to approximately 5%
Benefits:
- Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package
- Travel up to approximately 5%
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