Das ist der Job
The Role Act as the Global Regulatory Lead for assigned development programs.
Darum lohnt es sich
Serve as the primary regulatory representative within cross-functional project teams. Global Regulatory Lead (GRL) – Multiple Therapeutic Areas (Contract) - Canada
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. Develop and execute global regulatory strategies aligned with program objectives and timelines. Lead regulatory activities across clinical development, registration, and lifecycle management.
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 regula
