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Associate Director, Global Regulatory Advertising and Promotion

142 500 - 256 500$
Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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