Associate Director - Regulatory Advertising and Promotion

October 1

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Apellis Pharmaceuticals

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Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• Position Summary: The Associate Director, Regulatory Advertising & Promotion will lead compliance strategies for promotional materials. • Ensure compliance with regulatory agencies requirements and meeting strategic objectives. • Monitor regulatory compliance trends and provide training for advertising and promotion activities. • Collaborate with commercial and marketing teams to develop advertising and promotional materials.

Requirements

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred) • At least 8 years’ experience in pharmaceutical or biotech industry in multiple phases of development. • Minimum of 4 years Regulatory Affairs experience in advertising and promotion. • Experience working with OPDP. • Previous experience guiding a commercial team through the FDA approval & launch process (either NME approval or new indication approval). • Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion. • Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus. • Ability to work in a fast-paced, technically challenging environment where drive is critical to success. • Proficient computer skills; able to use standardized office software products, such as Microsoft Word, Excel, PowerPoint, SharePoint, SmartSheets etc. • Effective interpersonal skills with strong organizational skills. • Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence across all business functions in order to reach resolution. • Strong writing, project management and communication skills. • Other duties as required.

Benefits

• health insurance with full premium coverage • 401K with company match • paid time off (PTO) • long-term disability insurance • life insurance • more!