Global Regulatory Strategy Lead, Cross-Regional

Biopharma Asia; Raritan (NJ); On-site; USD 120,000 - 207,000; Full time

Job summary

Johnson & Johnson seeks a Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA.

The role focuses on implementing regional regulatory strategies for marketed and development products across multiple regions, in a matrix environment, with strong leadership and collaboration across Global and Local Operating Companies.

Qualifications

• Bachelor's degree with 8 years relevant experience (5 years pharm regulatory).
• Masters/PharmD with 6 years relevant experience (4 years pharm regulatory).
• PhD with 4 years relevant experience (3 years pharm regulatory).
• Breadth of global regulatory affairs experience in global drug development and commercialized products.

Responsibilities

• Implement regional regulatory strategy and submission plans aligned with R&D, regional and local objectives.
• Represent regions and contribute to regional and global regulatory strategy in cross-functional teams.
• Advise product teams on regional/local requirements and impact of supply chain decisions on registrations.
• Lead Regional Working groups to ensure timely execution and align regional with global deliverables.
• Facilitate tactical implementation at regional level with ongoing communication to regional/global teams.
• Develop regional marketing approval submission plans and prepare submission documents for product life cycle.
• Prepare registration dossiers (iCTD/ACTD) and manage country-specific submission requirements.

Skills

AI Judgement

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Strategic Thinking

Technical Credibility

Education

Bachelor's degree in Pharmaceuticals

Masters/PharmD

PhD

Tools

Copilot

Job description

Johnson & Johnson seeks a Manager, Cross-Regional Operations & Strategic Support Regional Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA.

The role focuses on implementing regional regulatory strategies for marketed and development products across multiple regions, in a matrix environment, with strong leadership and collaboration across Global and Local Operating Companies.