Director, Regulatory Affairs, Advertising & Promotion Review (PMRC)

Azurity 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 www.azurity.com.

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.

Brief team/department description:

Responsible for leading a high-performing team of experts in providing sound regulatory advice in the review of advertising and promotional materials for prescription drug products while minimizing the risk of regulatory action and competitively positioning drug products consistent with applicable FDA regulations and Azurity procedures and policies. The Sr. Director/Director will act as a credible, influential, respected spokesperson during interactions with FDA’s Office of Prescription Drug Promotion (OPDP) and/or other Global Health Authority reviewers. The Regulatory Director/Sr. Director will lead and provide consultative support to PMRC team members, such as Medical, Legal, Marketing and Commercial for issues/strategies relating to continuity between development plans and company objectives.

Principle Responsibilities:

• Lead and mentor a team of regulatory experts in the review of submissions to FDA’s OPDP and other global Health Authorities.
• Prepare (author) responses, negotiate, and/or formally interact with FDA’s OPDP and other global Health Authorities
• Provide Regulatory review and approval for all promotional materials to ensures accuracy, fair balance, and compliance with applicable regulations.
• Monitor enforcement trends/actions pertaining to advertising and promotion and communicate changes and implications to internal stakeholders.
• Chair high-volume Azurity PMRC meetings with leaders from Medical, Legal, Marketing and Commercial departments, sharing the regulatory perspective with the goal of enabling the business while mitigating risk.
• Partner and build strong relationships cross-functionally with Medical, Legal, Marketing, and Commercial groups to ensure promotional content is scientifically rigorous and compliant.
• Provide guidance to drug product development and marketing brand teams on advertising and promotional considerations during launch planning, and lifecycle management.
• Collaborate with Regulatory Product Lead(s) regarding labeling, providing strategic input on the promotional implications of new product labeling and lifecycle labeling changes including new claims, safety updates and other changes.
• Develop, implement, and continuously improve processes, SOPs, Work Instructions, and best practices for the review and approval of advertising and promotional materials.

Qualifications and Education Requirements

• Bachelor of Science in a scientific discipline; Master’s or advanced degree preferred.
• 15+ years direct Regulatory Affairs experience with at least 10+ years of experience in regulatory review of promotional materials for prescription drug products.
• Proven track record in managing promotion review committees (e.g. PMRC), and with mentoring and developing junior regulatory team members.
• Deep knowledge and expertise in FDA / OPDP regulations and guidance, global promotional guidance.
• Solutions oriented leader with demonstrated ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Marketing) and drive alignment while following regulatory regulations and requirements.
• Attention to detail, strong written and verbal communication skills.
• Proven success in managing large, complex, time-sensitive projects in a regulated environment.

#LI-Hybrid

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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 required

Benefits We Offer:

• 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*
• 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 time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
• 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.
• 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.

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