7 дней назад
Senior Manager Regulatory Affairs Advertising and Promotion
122 250 - 176 583$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager Regulatory Affairs Advertising and Promotion (Pharmaceutical Regulatory Affairs): Conducting independent reviews of advertising, promotional, communications, and medical materials while developing regulatory strategies for product promotion, launches, labeling, and product defense with an accent on FDA compliance, risk assessment, and cross-functional collaboration. Focus on leading advertising and promotion reviews, advising brand teams on regulatory risks and benefits, and serving as the regulatory liaison for assigned products.
Location: Morristown, NJ or Cambridge, MA; hybrid. US and Puerto Rico residents only.
Salary: $122,250–$176,583.33 per year
Company
is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.
What you will do
- Conduct independent regulatory reviews of advertising, promotional, communications, commercial, and medical materials.
- Develop and implement regulatory strategies for promotion, advertising campaigns, product launches, labeling, product defense, and development projects.
- Identify product-specific and therapeutic-area advertising and promotion issues and propose risk-based solutions.
- Represent Regulatory Affairs on brand teams and review committees, collaborating with commercial, medical, legal, marketing, and R&D groups.
- Provide regulatory guidance and risk-benefit analysis to support product development, promotion, advertising, reimbursement, and lifecycle management.
- Serve as the primary liaison with the FDA on advertising and promotional compliance matters for assigned products.
Requirements
- Bachelor’s degree from an accredited four-year college or university; a science focus is preferred.
- At least 3 years of experience in pharmaceutical or medical device advertising and promotional review.
- Relevant regulatory experience and a successful track record in the field.
- Experience working effectively with cross-functional groups, including Medical, Legal, Marketing, Commercial, and R&D.
- Knowledge of complex medical and scientific subjects, medical terminology, the U.S. pharmaceutical marketplace, and FDA-related promotional compliance.
- Strong written and oral communication, analytical, prioritization, multitasking, collaboration, and problem-solving skills.
Culture & Benefits
- Supportive, future-focused environment centered on scientific innovation and patient impact.
- Career development opportunities through promotion and lateral moves, including international opportunities.
- Employee rewards and benefit programs, including healthcare, prevention, and wellness support.
- At least 14 weeks of gender-neutral parental leave.
- Work at the intersection of biopharma, AI, data, and digital platforms.
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