Azurity Pharmaceuticals
VP, Regulatory Advertising & Promotion (PMRC)
Azurity Pharmaceuticals, Boston, Massachusetts, us, 02298
VP, Regulatory Advertising & Promotion (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.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
This executive role provides strategic leadership and regulatory counsel in navigating the complex landscape of prescription drug advertising and promotion. The role holder will develop and execute strategies that ensure stringent compliance with global health authority regulations (e.g., FDA, MHRA, OPDP) while maximizing the commercial potential and competitive positioning of Azurity’s product portfolio.
Key Strategic Accountabilities
Executive Regulatory Counsel & Risk Architecture:
Influence and drive interpretation and application of advertising and promotion regulations. Design proactive risk‑mitigation architectures that anticipate evolving regulatory landscapes, enabling aggressive yet compliant promotional campaigns.
Agency Negotiation & Influence (FDA/Global HAs):
Serve 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:
Act as a key commercial thought partner, providing consultative leadership to cross‑functional executive teams (Medical, Legal, Marketing, Commercial). Ensure seamless integration between regulatory strategy, long‑term development plans, and enterprise–level commercial objectives.
Competitive Advantage through Compliance:
Translate regulatory expertise into a tangible competitive advantage. Develop innovative promotional approaches while maintaining ironclad compliance to position products ethically and effectively.
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, enhancing 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 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), 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 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 global promotional guidance.
Ability to collaborate and influence cross‑functionally (Medical, Legal, Commercial, Marketing) while following regulatory regulations and requirements.
Attention to detail, strong written and verbal communication skills.
Benefits We Offer
Unlock Your Earning Potential:
Competitive compensation package with an annual bonus based on company performance. Sales‑only employees receive an incentive compensation program that allows them to earn more and receive a car reimbursement program and gas card for business and personal use.
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. Excludes Sales, Manufacturing, and some Operations positions.
Invest in Your Future:
401(k) plan with dollar‑for‑dollar matching up to 5%.
Time Off That Counts:
Up to 15 vacation days annually (with rollover up to 40 hours) plus five sick/wellness days. New employees accrue vacation prorated based on start date.
Meaningful Time with Loved Ones:
Company closed between Christmas and New Year’s to give employees a week off.
Enjoy the Holidays:
13 recognized holidays per year.
Invest in Your Education:
Tuition reimbursement for undergraduate and graduate courses or certifications.
Recognize and Be Recognized:
Azurity High Five peer recognition platform.
Prior to employment, consent to a background check and drug screen is required.
#J-18808-Ljbffr
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
This executive role provides strategic leadership and regulatory counsel in navigating the complex landscape of prescription drug advertising and promotion. The role holder will develop and execute strategies that ensure stringent compliance with global health authority regulations (e.g., FDA, MHRA, OPDP) while maximizing the commercial potential and competitive positioning of Azurity’s product portfolio.
Key Strategic Accountabilities
Executive Regulatory Counsel & Risk Architecture:
Influence and drive interpretation and application of advertising and promotion regulations. Design proactive risk‑mitigation architectures that anticipate evolving regulatory landscapes, enabling aggressive yet compliant promotional campaigns.
Agency Negotiation & Influence (FDA/Global HAs):
Serve 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:
Act as a key commercial thought partner, providing consultative leadership to cross‑functional executive teams (Medical, Legal, Marketing, Commercial). Ensure seamless integration between regulatory strategy, long‑term development plans, and enterprise–level commercial objectives.
Competitive Advantage through Compliance:
Translate regulatory expertise into a tangible competitive advantage. Develop innovative promotional approaches while maintaining ironclad compliance to position products ethically and effectively.
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, enhancing 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 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), 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 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 global promotional guidance.
Ability to collaborate and influence cross‑functionally (Medical, Legal, Commercial, Marketing) while following regulatory regulations and requirements.
Attention to detail, strong written and verbal communication skills.
Benefits We Offer
Unlock Your Earning Potential:
Competitive compensation package with an annual bonus based on company performance. Sales‑only employees receive an incentive compensation program that allows them to earn more and receive a car reimbursement program and gas card for business and personal use.
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. Excludes Sales, Manufacturing, and some Operations positions.
Invest in Your Future:
401(k) plan with dollar‑for‑dollar matching up to 5%.
Time Off That Counts:
Up to 15 vacation days annually (with rollover up to 40 hours) plus five sick/wellness days. New employees accrue vacation prorated based on start date.
Meaningful Time with Loved Ones:
Company closed between Christmas and New Year’s to give employees a week off.
Enjoy the Holidays:
13 recognized holidays per year.
Invest in Your Education:
Tuition reimbursement for undergraduate and graduate courses or certifications.
Recognize and Be Recognized:
Azurity High Five peer recognition platform.
Prior to employment, consent to a background check and drug screen is required.
#J-18808-Ljbffr