Global Regulatory Strategy Leader

KMR Search Group; United States; Remote; USD 180,000 - 320,000; Full time

Job summary

KMR Search Group is seeking a senior leader to oversee the global regulatory department, guiding a team of regulatory professionals in operations, strategy, labeling, and medical writing for both approved products and pipelines.

You will lead interactions with regulatory authorities worldwide (USA, EU, JAPAC), shape global submissions, ensure compliance with regulatory requirements, and partner with development teams to align timelines and deliverables.

Qualifications

• BS/MS/JD/MD/PhD in Life Sciences or equivalent.
• 15+ years in regulatory affairs with 10+ years in leadership in Pharma/Biotech.
• Strong leadership, proactive, and communication skills.
• Experience with USA, EU and JAPAC regulatory interactions.
• Familiarity with cGMP and regulatory (CMC, preclinical) compliance.

Responsibilities

• Lead the global regulatory strategy for products (approved and pipeline).
• Oversee regulatory operations, labeling, medical writing, and submissions.
• Interact with global regulatory authorities and lead advisory meetings.
• Coordinate with Leadership and Development Teams on regulatory milestones.
• Ensure timely approvals of INDs/clinical trial applications and CMC deliverables.

Skills

Regulatory leadership

Global regulatory strategy

Communication skills

Influential

Stakeholder management

Regulatory affairs

Education

Life sciences degree

Job description

KMR Search Group is seeking a senior leader to oversee the global regulatory department, guiding a team of regulatory professionals in operations, strategy, labeling, and medical writing for both approved products and pipelines.

You will lead interactions with regulatory authorities worldwide (USA, EU, JAPAC), shape global submissions, ensure compliance with regulatory requirements, and partner with development teams to align timelines and deliverables.