Regulatory Affairs Director jobs in Raleigh, NC

Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization. Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines.  Serve as a liaison and subject matter expert (SMA) on the interpretation of US Labeling and Advertising/Promotional FDA guidance documents and regulations.

Duties & Responsibilities:

• Responsible for providing commercial regulatory strategy and leadership for promotional materials.
• Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components.
• Perform regulatory review of advertising and promotional materials, as required.
• Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks.
• Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components.
• Knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP).
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
• Knowledge of pharmaceutical labeling, packaging components, graphic arts capabilities (ADOBE® Illustrator/XML), and SPL labeling process.
• Track record of successfully working with third-party vendors.
• Create/revise SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes. 
• Continuously monitor the regulatory environment for new regulations, guidance, and enforcement.
• Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met​. 

Qualifications:

• Bachelor’s degree in Life Science or other related discipline. At least 10 years’ experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review.  A combination of education and applicable job experience may be considered.
• Experience leading team members, fostering a culture of efficiency and teamwork.
• Demonstrated track record of successful product launches.
• Strong expertise and knowledge of Advertising/Promotional regulations and guidance.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading skills.​

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