Contract Opportunities

Global Regulatory Lead - Immunology/Pulmonary

Contract: TBC

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We are seeking an experienced Global Regulatory Lead (GRL) to provide coverage for medical leave within a key regulatory leadership position. This individual will lead global regulatory strategy and execution across immunology and pulmonary programs, with a particular focus on pulmonary fibrosis and autoimmune disease indications.

The successful candidate will bring strong pharmaceutical or biotechnology industry experience and a proven track record of leading regulatory filings and submissions through to successful completion.

They will work closely with cross-functional teams to drive regulatory activities and support interactions with health authorities.

The Role

Act as the Global Regulatory Lead for assigned immunology and pulmonary development programs.
Develop and implement global regulatory strategies aligned with development and business objectives.
Provide regulatory leadership and strategic guidance to cross-functional project teams.
Lead the planning, preparation, review, and submission of regulatory filings to FDA and other global health authorities.
Serve as the primary regulatory representative for program teams and governance discussions.
Lead regulatory activities across the product lifecycle, including development, registration, and post-approval activities.
Coordinate responses to regulatory authority questions and information requests.
Support and lead preparations for health authority meetings and regulatory interactions.
Identify regulatory risks and opportunities and develop appropriate mitigation strategies.
Ensure all regulatory deliverables are completed in accordance with applicable regulations and project 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.
Experience in Immunology, Pulmonary, Autoimmune Diseases, and/or Pulmonary Fibrosis is highly desirable.
Demonstrated experience as a Global Regulatory Lead (GRL) or equivalent regulatory leadership role.
Proven experience leading regulatory filings and submissions from strategy through submission.
Strong understanding of FDA regulations and global regulatory requirements.
Experience working within complex, 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).
Experience interacting directly with FDA and other health authorities.
Prior experience within both global and U.S. regulatory environments.

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 strongly preferred.