Director, Regulatory Affairs - Clinical Regulatory Strategy and Advertising/Promotional

Azurity Pharmaceuticals - Atlanta, GA

Full-time - Senior

Hybrid - Atlanta, GA

Chemical Manufacturing

About the position

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.
• 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.

Requirements

• 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 through 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)

Benefits

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
• Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
• Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
• Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
• Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions.
• Start Your Week on a High Note: Indulge in our 'Bagel Tuesday' perk, where you can enjoy a fresh bagel on us every Tuesday morning. Only for On-site/Hybrid colleagues.
• Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
• Time Off That Counts: Take advantage of our generous PTO policy, which offers 20 days annually + rollover (up to 40 hours).
• Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
• Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
• Summer Vibes: Embrace the summer season with our Summer-Hours perk, available between Memorial Day and Labor Day. Excludes Sales Colleagues.
• Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
• Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.