Contract Opportunities

Global Regulatory Lead - Neuroscience

Contract: 6 months (with potential extension)

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We are seeking an experienced Global Regulatory Lead (GRL) to support a neuroscience-focused development portfolio. This is an excellent opportunity for a senior regulatory professional with strong neuroscience experience and a proven ability to lead complex regulatory strategies and submissions.

The successful candidate will provide regulatory leadership across development programs, partnering with cross-functional teams to drive global regulatory activities and support interactions with health authorities.

Given the specialist nature of the role, prior experience in neuroscience regulatory affairs is essential.

The Role

Act as the Global Regulatory Lead for assigned neuroscience programs.
Develop and execute global regulatory strategies aligned with development and commercial objectives.
Provide strategic regulatory guidance to cross-functional teams throughout the product development lifecycle.
Lead the planning, preparation, review, and submission of regulatory filings to the FDA and other global health authorities.
Serve as the primary regulatory representative for project teams and governance discussions.
Lead regulatory activities supporting clinical development, registration, and lifecycle management.
Coordinate responses to health authority questions and requests for information.
Support and lead preparations for regulatory agency meetings and interactions.
Identify regulatory risks, opportunities, and mitigation strategies.
Ensure regulatory deliverables are completed to the highest quality standards and within agreed timelines.

Requirements

Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
Significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
Demonstrated experience as a Global Regulatory Lead (GRL) or equivalent senior regulatory leadership role.
Essential: Direct regulatory experience within Neuroscience/Central Nervous System (CNS) programs.
Proven experience leading major regulatory filings and submissions from strategy through successful submission.
Strong knowledge of FDA regulations and global regulatory requirements.
Experience working effectively within cross-functional drug development teams.
Excellent communication, stakeholder management, and leadership skills.

Preferred Experience

Experience supporting late-stage development programs and major submissions (INDs, NDAs, BLAs, MAAs).
Direct experience interacting with FDA and other global regulatory authorities.
Experience working across multiple regions within a global regulatory framework.

Additional Information

Candidates must be based in the United States.
Remote working is acceptable.
Ability and willingness to travel occasionally for important meetings and business-critical activities.
Immediate availability or ability to start at short notice is highly desirable.