Regional Regulatory Strategy Manager - Cross-Region Ops

6084-Janssen Research & Development, LLC Legal Entity; Raritan (NJ); On-site; USD 120,000 - 207,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Cross-Regional Operations & Strategic Support in Regulatory Affairs to lead regional regulatory strategy across multiple territories from a base in the U.S. This role coordinates with Global Regulatory Leaders and Local Operating Companies to implement regulatory plans for marketed products and pipelines.

The position requires extensive global regulatory experience, strong leadership in a matrix environment, and the ability to manage complex submissions,

Qualifications

• Global regulatory affairs experience in drug development and commercialization.
• Experience in AP/LA/EMEA regions desirable.
• Ability to independently manage multiple projects and work in a matrix environment.

Responsibilities

• Implement the regional regulatory strategy and submission plans in line with regional objectives.
• Represent regions and contribute to global/regional regulatory strategy in cross-functional teams.
• Advise product teams on regional/local regulatory requirements and supply chain impacts.
• Lead Regional Working Groups to meet product objectives and align with global teams.
• Facilitate regulatory communications with Health Authorities and inspections as needed.
• Develop regional marketing approval submission plans and manage dossiers (iCTD/ACTD).
• Manage country-specific submission requirements and labeling strategies.

Skills

AI Judgement Integration

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Fact-Based Decision Making

Industry Analysis

Legal Support

Process Improvements

Product Licensing

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Strategic Thinking

Technical Credibility

Education

Bachelor's degree + 8 years pharm regulatory experience

Masters/PharmD + 6 years pharm regulatory experience

PhD + 4 years pharm regulatory experience

Tools

Copilot

Job description

Johnson & Johnson is seeking a Manager, Cross-Regional Operations & Strategic Support in Regulatory Affairs to lead regional regulatory strategy across multiple territories from a base in the U.S. This role coordinates with Global Regulatory Leaders and Local Operating Companies to implement regulatory plans for marketed products and pipelines.

The position requires extensive global regulatory experience, strong leadership in a matrix environment, and the ability to manage complex submissions,