Azurity Pharmaceuticals
VP, Regulatory Advertising & Promotion (PMRC)
Azurity Pharmaceuticals, Boston, Massachusetts, us, 02298
VP, Regulatory Advertising & Promotion (PMRC)
Join as the executive leader in regulatory advertising and promotion at Azurity Pharmaceuticals, a privately held specialty pharmaceutical company focused on innovative products for underserved patients. Azurity’s mission is to bring high‑quality medications to cardiovascular, neurology, endocrinology, gastro‑intestinal, institutional, and orphan markets. Learn more at www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer.
Key Strategic Accountabilities
Executive Regulatory Counsel & Risk Architecture: Influence and drive interpretation and application of advertising and promotion regulations, proactively designing risk mitigation architectures for compliant promotional campaigns.
Agency Negotiation & Influence (FDA/Global HAs): Act as the primary liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) and other global regulatory bodies, leading high‑stakes negotiations and shaping dialogue around novel promotional strategies.
Integrated Commercial Strategy Leadership: Provide consultative leadership to cross‑functional executive teams (Medical, Legal, Marketing, Commercial) and integrate regulatory strategy with long‑term development plans and enterprise‑level commercial objectives.
Competitive Advantage through Compliance: Translate deep regulatory expertise into a tangible competitive advantage by developing innovative promotional approaches that maintain ironclad compliance and strategically position drug products to capture market share effectively and ethically.
Principal 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.
Developed and executed 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.
Served 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.
Influenced 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.
Qualifications and Education Requirements
Bachelor of Science in a scientific discipline; master’s or advanced degree preferred.
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 the global regulatory environment and 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.
Physical & Mental Requirements
Must be able to sit for long periods of time.
Employee frequently required to stand; walk; sit; talk and/or hear.
May occasionally climb stairs and/or ride elevators.
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:
Reward with a competitive compensation package, including an annual bonus based on company performance.
Comprehensive Health Coverage:
Excellent medical, dental, vision, and prescription coverage for you and your family.
Flexibility for Your Lifestyle:
Hybrid work model – two days from home and three days in the office (excluding Sales, Manufacturing, and some Operations positions).
Invest in Your Future:
Retirement Savings Plan (401(k)) with dollar‑for‑dollar match up to 5%.
Time Off That Counts:
Generous vacation policy – up to 15 vacation days annually (rollover up to 40 hours) plus five sick/wellness days.
Meaningful Time with Loved Ones:
Company closes between Christmas and New Year’s for an extra week off.
Enjoy the Holidays:
13 company holidays per year.
Invest in Your Education:
Tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized:
Azurity High Five peer recognition platform.
Legal Statements The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
#J-18808-Ljbffr
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer.
Key Strategic Accountabilities
Executive Regulatory Counsel & Risk Architecture: Influence and drive interpretation and application of advertising and promotion regulations, proactively designing risk mitigation architectures for compliant promotional campaigns.
Agency Negotiation & Influence (FDA/Global HAs): Act as the primary liaison to the FDA’s Office of Prescription Drug Promotion (OPDP) and other global regulatory bodies, leading high‑stakes negotiations and shaping dialogue around novel promotional strategies.
Integrated Commercial Strategy Leadership: Provide consultative leadership to cross‑functional executive teams (Medical, Legal, Marketing, Commercial) and integrate regulatory strategy with long‑term development plans and enterprise‑level commercial objectives.
Competitive Advantage through Compliance: Translate deep regulatory expertise into a tangible competitive advantage by developing innovative promotional approaches that maintain ironclad compliance and strategically position drug products to capture market share effectively and ethically.
Principal 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.
Developed and executed 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.
Served 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.
Influenced 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.
Qualifications and Education Requirements
Bachelor of Science in a scientific discipline; master’s or advanced degree preferred.
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 the global regulatory environment and 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.
Physical & Mental Requirements
Must be able to sit for long periods of time.
Employee frequently required to stand; walk; sit; talk and/or hear.
May occasionally climb stairs and/or ride elevators.
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:
Reward with a competitive compensation package, including an annual bonus based on company performance.
Comprehensive Health Coverage:
Excellent medical, dental, vision, and prescription coverage for you and your family.
Flexibility for Your Lifestyle:
Hybrid work model – two days from home and three days in the office (excluding Sales, Manufacturing, and some Operations positions).
Invest in Your Future:
Retirement Savings Plan (401(k)) with dollar‑for‑dollar match up to 5%.
Time Off That Counts:
Generous vacation policy – up to 15 vacation days annually (rollover up to 40 hours) plus five sick/wellness days.
Meaningful Time with Loved Ones:
Company closes between Christmas and New Year’s for an extra week off.
Enjoy the Holidays:
13 company holidays per year.
Invest in Your Education:
Tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized:
Azurity High Five peer recognition platform.
Legal Statements The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
#J-18808-Ljbffr