Reporting to the VP, North America Regulatory Affairs the Director, Regulatory Affairs Advertising and Promotion will manage regulatory strategy, and material approvals for areas of responsibility and ensure these activities are consistent with the overall company strategy.
In conjunction with VP, North America Global Regulatory Affairs s/he will be responsible for devising and implementing regulatory strategy, ensuring regulatory compliance, providing regulatory advice and counseling for assigned areas of responsibility, and supporting launch and commercialization across the lifecycle of products for responsible territories.
A crucial part of this role is ensuring strong coordination and collaboration across internal departments and stakeholders including the Clinical, Commercial, Medical Affairs, Pharmacovigilance, and Compliance organizations.
Specific Responsibilities:
• Guide, direct and coordinate the strategic advertising/promotion and MRL planning for company products from a regulatory perspective for pre and post launch campaigns
• Maintain oversight and efficiency of systems for managing review and approval of non-promotional (MRL) and/or advertising and promotional materials
• Provide input into or develop required processes, including transitioning of acquired products into company systems and associated standard operating procedures to ensure consistency of approach and regulatory compliance for areas of responsibility
• Manage regulatory affairs advertising and promotion/MRL staff members and provide direction on business milestones and timelines
• Perform routine process check and incorporate better practices as continuous process improvements for commercial products and processes
• Train, mentor, and develop direct reports and other internal staff as appropriate
• Apply critical review skills and creative solutions to diverse promotional and MRL scenarios
• Develop and maintain relationships with the FDA (OPDP, APLB, Office of Compliance) on advertising and promotional labeling-related activities
• Ensure that advertising and promotional, MRL and labeling materials meet FDA and Aimmune standards for assigned products
• Ensure promotional regulatory activities support business needs while appropriately mitigating promotional risk
• Survey, evaluate and interpret regulatory requirements relative to advertising and promotional labeling and disseminate information on impact of changes to appropriate stakeholders
• Provide relevant input into development or update of product labeling, upon request
Preferred Experience, Special Skills, Knowledge:
• BS in relevant degree; an advanced degree is preferred.
• 10+ years of experience in Regulatory Affairs within the pharmaceutical industry with 2 years of leadership and management experience.
• Experience in reviewing and approving advertising and promotion as well as non-promotional materials within a complex specialty/branded commercial pharmaceutical organization.
Preferred candidates will have experience in critically reviewing and implementing collaborative solutions to diverse promotional and MRL scenarios.
• Good interpersonal skills as well as a sound strategic business perspective with appropriate consideration to risk is required to ensure that effective regulatory and compliance practices are fully integrated into all associated development and post-marketing activities.
• Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America.
In-depth understanding of the product commercialization and labeling development process is desired.
• The ability to assimilate and interpret trends in the North American advertising and promotion and compliance environment that directly affect business decisions impacting areas of responsibility.
• Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
• This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
S/he will be innovative, hands-on, and team oriented, with the ability to think strategically as well as execute project details.
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption.
Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies.
In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions