Associate Director, Regulatory Legal

1 week ago


Plymouth Meeting, Pennsylvania, United States Organon Full time
Job DescriptionThe Role

We are looking for someone to provide legal support and advice on FDA regulatory and compliance matters for our commercial, research & development, and manufacturing teams.

Responsibilities
  • Partnering with stakeholders to assess risks and offer practical regulatory advice.
  • Interpreting regulations, handling enforcement actions, and collaborating with external legal counsel.
  • Supporting the commercial organization as part of the Promotion Review Committee.
  • Offering legal guidance to various departments such as labeling, quality, and regulatory affairs.
  • Preparing clients for regulatory inspections and assisting with regulatory submissions.
  • Providing advice on clinical assets, marketed products, and other regulatory issues.
  • Guiding on state licensing and environmental, health, and safety matters.
  • Supporting business development, quality investigations, and trade compliance.
Requirements
  • Bachelor's degree from an accredited institution.
  • Law degree from a US law school and admitted to the Bar in a specific state.
  • Minimum of 5 years of legal experience in a law firm or corporate environment.
  • Strong communication, analytical skills, and business acumen.
  • Ability to manage a busy workload and adapt to fast-paced environments.
  • Experience in ambiguous situations and strong problem-solving skills.
  • Proactive nature and prior exposure to pharmaceutical products.
Preferred Skills
  • Experience with medical devices and combination products.
  • Knowledge of GxP and FDA regulations.

Up to 10% travel may be required.

About Us

Join us at Organon, a global healthcare company dedicated to empowering women and their communities through innovative health solutions. Our goal is to enhance women's health, broaden access to biosimilars, and offer a diverse portfolio of health products. Our vision is to create a healthier world for all women.

US and PR Residents Only

Organon is an equal opportunity employer committed to diversity and inclusion.



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