Azurity Pharmaceuticals · 1 day ago
VP, Regulatory Advertising & Promotion (PMRC)
Boston, MA
Full-time
Hybrid
Director/Executive
20+ years expAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. The VP, Regulatory Advertising & Promotion will provide strategic leadership and regulatory counsel to ensure compliance with global health authority regulations while maximizing the commercial potential of Azurity's product portfolio.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Spearheaded the design and implementation of a harmonized, enterprise-wide Global PMRC framework, standardizing risk assessment and benefit-risk evaluation processes across all product portfolios and international jurisdictions
Chair the Global Pharmacovigilance Risk Management Council (PMRC), leading strategic initiatives to identify, assess, and mitigate emerging safety signals, resulting in enhanced patient safety and regulatory compliance worldwide
Managed regulatory engagement and submissions for complex drug safety issues with a wide array of international health authorities, including the EMA, MHRA, Health Canada, and the China National Medical Products Administration (NMPA), ensuring alignment with diverse regional requirements
Develop and execute global compliance strategies for post-market surveillance and aggregate reporting (e.g., PBRERs), consistently achieving a 98% timely submission rate across FDA, EU, and other global markets
Serve as the primary liaison during major regulatory inspections and audits (e.g., EMA, MHRA), successfully demonstrating the robustness and effectiveness of the global PV system and ensuring positive inspection outcomes
Influence global regulatory convergence by participating in initiatives aligned with ICH guidelines and the International Coalition of Medicines Regulatory Authorities (ICMRA) objectives, helping to shape future regulatory standards
Qualification
Required
Bachelor of Science in a scientific discipline
20+ years of regulated industry experience including regulatory review of promotional materials for prescription drug products
Proven track record in management of promotion review committees (e.g. PMRC)
Deep knowledge and expertise in global regulatory environment, and global promotional guidance
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
Preferred
master's or advanced degree
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•
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.
Company
Azurity Pharmaceuticals
Azurity Pharmaceuticals is a developer of drug products and technologies to address the needs of patients.
501-1000 employees
H1B Sponsorship
Azurity Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (4)
Funding
Current Stage
Late StageTotal Funding
$20MKey Investors
Ampersand Capital Partners
2018-03-26Acquired
2015-01-06Private Equity
2014-12-30Series Unknown· $20M
Leadership Team
Vinicius de Lima
Chief Medical Officer
Recent News
Azurity Pharmaceuticals
2025-11-18
Company data provided by crunchbase