Global Regulatory Strategy Director

Regulatory Toolkit; Washington (District of Columbia); Hybrid; USD 112,000 - 236,000; Full time

Job summary

Mylan Inc. is seeking a Director, Regulatory Strategist to lead global/regional regulatory strategies for complex product projects.

You will partner with Clinical, Safety, Medical, Quality, R&D, Commercial and Legal teams to ensure timely, compliant submissions and high-quality regulatory documents. You will provide strategic input to development programs, participate in labeling decisions, monitor plans, and communicate risks to senior leadership.

Qualifications

• B.S. Scientific Degree required; advanced degree (Ph.D./ Pharm.D./ M.D./ M.Sc.) preferred.
• Minimum 8 years of US/EU/EM Regulatory experience; global/regional experience preferred.
• Experience managing global/regional regulatory activities across drug development and lifecycle.

Responsibilities

• Develop global/regional regulatory strategies and implementation plans for complex projects; optimize delivery timelines and outcomes.
• Partner with Clinical, Safety, Medical, Quality, R&D, Commercial, Legal to align regulatory contributions with business needs.
• Provide regulatory input to clinical development programs and target label development.
• Serve on Product Labelling Team to update CCDS and labels with strategic input.
• Ensure regulatory plans are monitored and risks communicated to senior leadership.
• Develop submission packages and ensure documentation meets regulatory requirements for MAAs/registrations.

Skills

Regulatory strategy

Stakeholder management

Health Authority engagement

Regulatory project leadership

Regulatory environment knowledge

Negotiation with Health Authorities

Written and verbal communication

Education

B.S. Scientific Degree

Advanced degree preferred (Ph.D./ Pharm.D./ M.D./ M.Sc.)

MBA preferred

Job description

Mylan Inc. is seeking a Director, Regulatory Strategist to lead global/regional regulatory strategies for complex product projects.

You will partner with Clinical, Safety, Medical, Quality, R&D, Commercial and Legal teams to ensure timely, compliant submissions and high-quality regulatory documents. You will provide strategic input to development programs, participate in labeling decisions, monitor plans, and communicate risks to senior leadership.