Global Regulatory Lead – Multiple Therapeutic Areas
Contract: 9 months
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We are seeking experienced Global Regulatory Leads (GRLs) to support a range of development programs across multiple therapeutic areas. These positions will be based onsite at the client's office in Montreal and will provide regulatory leadership across various projects within the portfolio.
Candidates should have strong pharmaceutical or biotechnology industry experience and a proven track record of leading regulatory strategy, filings, and submissions. Experience in one or more therapeutic areas such as Oncology, Immunology, Neuroscience, or other specialty indications is highly desirable.
The Role
- Act as the Global Regulatory Lead for assigned development programs.
- Develop and execute global regulatory strategies aligned with program objectives and timelines.
- Lead regulatory activities across clinical development, registration, and lifecycle management.
- Serve as the primary regulatory representative within cross-functional project teams.
- Lead the planning, preparation, review, and submission of regulatory filings to health authorities.
- Support and lead regulatory agency interactions and meeting preparations.
- Provide strategic guidance on regulatory requirements, risks, and opportunities.
- Coordinate responses to health authority questions and information requests.
- Ensure all regulatory deliverables are completed in compliance with applicable regulations and project timelines.
Requirements
- Bachelor's degree in a 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.
- Proven experience leading regulatory filings and submissions through to successful completion.
- Experience within one or more therapeutic areas, including:
- Oncology
- Immunology
- Neuroscience
- Other complex or specialty disease areas
- Strong knowledge of FDA and global regulatory requirements.
- Experience working within multidisciplinary, cross-functional development teams.
- Excellent communication, stakeholder management, and leadership skills.
Preferred Experience
- Experience supporting major submissions, including INDs, NDAs, BLAs, MAAs, or equivalent.
- Direct experience interacting with FDA, Health Canada, and other global health authorities.
- Experience working within global development programs and complex regulatory environments.
Additional Information
- Candidates must be able to work onsite in Montreal.
- Immediate availability or ability to start at short notice is strongly preferred.
- Multiple opportunities may be available across different therapeutic areas.
How to Apply
This contract opportunity is exclusive to The Source.
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