Senior Leader, Regulatory Compliance and Strategy

6 days ago


Jersey City, New Jersey, United States Organon Full time
About the Role

We are seeking a highly experienced and skilled Executive Director, Group Head, Advertising and Promotion Oversight to join our team at Organon. This is a critical leadership role that will require a deep understanding of regulatory compliance and strategic planning.

Key Responsibilities
  • Lead a team of regulatory compliance specialists responsible for reviewing and approving advertising and promotional materials for compliance with FDA regulations and industry standards.
  • Develop and implement strategies to ensure compliance with evolving FDA regulations and industry standards.
  • Provide technical and professional leadership to the team, including guidance on regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams to develop and implement promotional strategies that meet regulatory requirements and business objectives.
  • Develop and maintain relationships with key stakeholders, including FDA representatives and industry partners.
  • Stay up-to-date on industry trends and developments, and apply this knowledge to inform regulatory compliance strategies.
  • Provide input on business development due diligence activities, including the assessment of promotional regulatory risks.
  • Develop and implement departmental strategic initiatives to drive business growth and improve regulatory compliance.
Requirements
  • Bachelor's degree in a relevant field, such as biological science, chemistry, or a related discipline.
  • 12-15 years of experience in drug or medical device development, with a strong background in advertising and promotion review.
  • Additional experience with ex-US promotional activities is highly desirable.
  • Demonstrated scientific knowledge, writing ability, effective communication, and familiarity with worldwide regulatory agencies.
  • Experienced in negotiations with health authorities.
  • Outstanding interpersonal, communication, and negotiation skills.
  • Demonstrated leadership attributes, including the ability to build and lead high-performing teams.
  • Ability to solve problems through investigation and solution identification.
  • High degree of professionalism and sound judgment, working well with others.
  • Driver of change and innovation.
  • Demonstrate sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments.
About Organon

Organon is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have a diverse and trusted portfolio of health solutions and are committed to delivering innovative health solutions that enable people to live their best lives.



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