Director, Regulatory Affairs - Azurity Pharmaceuticals - US
Woburn, MA
About the Job
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.
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.
#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*
- 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.
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