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Director, Regulatory Affairs - Clinical Regulatory Strategy and Advertising/Promotional - Atlanta Georgia
Company: Tbwa Chiat/Day Inc
Location: Atlanta, Georgia
Posted On: 01/19/2025
Director, Regulatory Affairs - Clinical Regulatory Strategy and Advertising/PromotionalAtlanta, GAAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit .Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.As a part of the Regulatory Affairs team at Azurity, this Regulatory Director will conduct in-depth analysis of regulatory and clinical information to determine the best regulatory and clinical pathway and strategy for potential drug products for development of the Azurity portfolio of medications. The Regulatory Director will report to the Vice President of Regulatory Affairs and work cross-functionally with other Azurity teams determining regulatory strategy including but not limited to Franchise Managers, Clinical Development, and Product Development. This person will play a critical role by providing the regulatory and clinical strategy for new products in development and potential new indications for approved products. The Regulatory Director will also direct the activities of Advertising/Promotional Review Teams. They will be responsible for providing Advertising/Promotional regulatory insight in line with applicable regulatory guidelines and will serve as a liaison and subject matter expert (SMA) on the interpretation of US Advertising/Promotional FDA guidance documents and regulations.Responsibilities: - Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA clinical and regulatory requirements.
- Knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics.
- Assessment of regulatory and clinical critical approval factors, including but not limited to, PK, PREA, and other post-marketing safety studies.
- Assessment of current regulatory pathways within relevant therapeutic areas to provide insight on potential future development opportunities to build the R&D pipeline.
- Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy.
- Experience with preparation of initial pediatric study plans and non-clinical and clinical sections in support of 505(b)(2) NDA submissions.
- Direct interaction and liaison with regulatory agencies as required.Advertising/Promotional:
- Responsible for providing commercial regulatory strategy and leadership for promotional materials.
- Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components.
- Advise internal teams and management on regulations, guidance, and industry best practices related to advertising/promotional components.
- Perform regulatory review of advertising and promotional materials, as required.
- Knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP).
- Recruit, develop and act as an advisor and coach to direct reports and 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.Preferred Qualifications:
- Education: Bachelor's degree in Life Science or other related discipline; advanced degree preferred (MS, PharmD, PhD)
- Experience: Minimum of 10 years of pharmaceutical industry experience; minimum of 5 years of regulatory experience including regulatory/clinical strategy and advertising/promotional review
- Experience leading team members, fostering a culture of efficiency and teamwork
- Strong expertise and knowledge of Advertising/Promotional regulations and guidance.
- Demonstrates passion for research, brings innovation to challenging projects, and possesses a willingness to learn and work across diverse therapeutic areas and modalities
- Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely
- Strategic thinker who possesses rigorous scientific proficiency and solid business acumen with the ability to look beyond the current state to identify unique opportunities
- Sound understanding of the drug development continuum with thorough knowledge of regulatory approval processes
- Adept at handling multiple projects and tight deadlines in a fast-paced environment
- Strong quantitative analytical skills, including proficiency with Excel, PowerPoint (or equivalent)Physical & Mental Requirements:
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as requiredBenefits We Offer:
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