1 день назад
Associate Director, Global Regulatory Advertising and Promotion
142 500 - 256 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Global Regulatory Advertising and Promotion (FDA/OPDP): Ensuring compliance of promotional, corporate, and disease-awareness materials across communication channels with an accent on FDA requirements, cross-functional review, and global regulatory frameworks. Focus on preparing 2253 submissions, supporting APLB interactions, training stakeholders, and proactively mitigating advertising and promotion risks.
Location: Cambridge, Massachusetts, United States; 70% in-office work model.
Salary: $142,500–$256,500 per year, plus potential discretionary bonus, incentive compensation, or equity.
Company
develops mRNA technology and medicines, with a focus on scientific progress and improving how medicines are created and delivered.
What you will do
- Review and approve promotional materials, corporate communications, and disease-awareness campaigns for compliance with FDA and applicable regulatory requirements.
- Guide advertising and promotion strategy during early product development.
- Lead assigned product discussions with Promotional Material Review Teams and Medical Review Committees alongside Marketing, Medical, Legal, Compliance, and Commercial stakeholders.
- Support FDA APLB and other health authority interactions, including regulatory queries.
- Prepare promotional-material submissions, including Form 2253 filings and advisory comment requests.
- Develop promotional-regulation training and improve SOPs, best practices, and review processes.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- At least 5 years of Regulatory Affairs experience, including at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry.
- Deep knowledge of US and global regulatory frameworks, FDA regulations, OPDP/APLB guidance, and enforcement trends.
- Experience working with cross-functional review committees in a regulated environment and preparing regulatory documentation.
- Strong written and verbal communication, problem-solving, attention to detail, and project-management skills.
- Only U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible because of U.S. export-control requirements; visa sponsorship for non-U.S. persons is unavailable.
Nice to have
- Advanced degree such as PharmD, JD, or Master’s in Regulatory Affairs.
- Global regulatory experience with EMA, Health Canada, or UK requirements.
- Experience with digital and social media promotional compliance.
- Experience in infectious diseases, oncology, rare diseases, or vaccines.
Culture & Benefits
- Hybrid 70/30 work model emphasizing in-office collaboration, teamwork, and mentorship.
- Healthcare coverage and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs, plus location-specific perks.
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