Associate Director, Regulatory Policy

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +4

The Associate Director, Regulatory Policy will provide leadership and subject-matter expertise in regulatory policy and compliance, supporting the development, interpretation, and implementation of global and regional regulatory requirements. This role will shape regulatory policy positions, ensure consistent compliance, and enable informed decision-making across the organization, partnering with Regulatory Affairs, Quality, Legal, and business stakeholders to manage regulatory risk and support sustainable business operations.

What you'd actually do

  1. Lead regulatory policy and compliance activities, ensuring alignment with applicable global, regional, and local regulatory requirements.
  2. Interpret evolving regulatory policies and guidance and assess impact on products, processes, and business strategies.
  3. Develop and maintain internal regulatory policies, standards, and guidance documents.
  4. Provide expert regulatory policy advice to cross‑functional stakeholders, including Regulatory Affairs, Quality, and business leaders.
  5. Support regulatory inspections, audits, and assessments related to policy and compliance topics.

Skills

Required

  • Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Law, or a related discipline
  • 8–10 years of progressive experience in regulatory affairs, regulatory policy, or compliance within a regulated industry
  • Strong understanding of global regulatory frameworks and policy development
  • Experience interpreting regulations and translating requirements into practical guidance
  • Proven ability to influence and advise senior stakeholders on regulatory policy matters
  • English required

Nice to have

  • Advanced degree or professional certification in Regulatory Affairs or Compliance
  • Experience in medical devices, healthcare, or other highly regulated industries
  • Exposure to regulatory inspections, audits, or authority interactions
  • Experience working in a global or matrixed organization
  • Demonstrated success driving regulatory or compliance process improvements
  • Familiarity with US, EU MDR, China and other major international regulatory frameworks
  • Effective written and verbal communication skills
  • Strong analytical, problem‑solving, and documentation skills
  • Additional European languages preferred
  • RAC or equivalent preferred

What the JD emphasized

  • global regulatory requirements
  • regulatory policy
  • compliance