Global Regulatory Strategy Director

Regulatory Jobs; Alameda, Northern (CA, KY); Hybrid; USD 248,000 - 353,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision insurance

Life and disability insurance

Stock options

Discretionary annual bonus

Vacation days

Job summary

Regulatory Jobs is seeking a senior Regulatory Affairs leader to drive global regulatory strategies that align with asset and corporate goals. You will interact with health authorities, guide study teams, and ensure timely, compliant submissions.

You will lead multi-asset programs, collaborate with external vendors for CTAs and INDs, and author high-quality regulatory documents. A strong background in regulatory requirements and leadership is essential.

Qualifications

• Bachelor’s degree in related discipline with extensive experience (15+ years) in regulatory affairs.
• Master’s degree with extensive experience (13+ years) in regulatory affairs.
• PhD with substantial regulatory experience (12+ years).
• Equivalency of education and experience considered for senior roles.

Responsibilities

• Interact directly with regulatory authorities and provide guidance to study and asset teams.
• Lead development and execution of global regulatory strategies across programs.
• Plan, review, submit, and maintain regulatory dossiers (CTAs, INDs, NDAs/BLA) with vendors.
• Review regulatory documents for regulatory alignment and quality.
• Lead and author submissions to health authorities and ensure compliance.

Skills

Regulatory strategy

Stakeholder communication

Team leadership

Regulatory intelligence

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

PhD degree in related discipline

Equivalent combination of education and experience

Job description

Regulatory Jobs is seeking a senior Regulatory Affairs leader to drive global regulatory strategies that align with asset and corporate goals. You will interact with health authorities, guide study teams, and ensure timely, compliant submissions.

You will lead multi-asset programs, collaborate with external vendors for CTAs and INDs, and author high-quality regulatory documents. A strong background in regulatory requirements and leadership is essential.