Senior Specialist CMC

Global Regulatory Strategy & Lifecycle Management

• Lead the evaluation and assessment of regulatory impact for proposed post-approval CMC changes including supplements variations and global lifecycle submissions.
• Contribute to global regulatory strategy as the CMC regulatory representative on drug development and product lifecycle teams.
• Ensure alignment of global CMC strategies across regions (US Canada EU APAC LATAM and other international markets).
• Interpret global regulations guidance documents and health authority expectations to inform post-marketing strategies and risk assessments.

Cross-Functional & Global Collaboration

• Provide guidance and regulatory direction to internal stakeholders (R&D Manufacturing QA/QC Medical Affairs Marketing Clinical/Medical Affairs etc.) to support product lifecycle maintenance.
• Coordinate information exchange between CMC Regulatory Affairs and global cross-functional partners affiliates and external manufacturing sites.
• Partner with Regulatory Operations to ensure timely and accurate submissions across all global markets.

Post-Marketing Regulatory Submissions & Compliance

• Plan author and submit CMC-related supplements variations annual updates renewals and health authority correspondence to global health authorities.
• Ensure submissions meet global regulatory requirements (FDA Health Canada EMA ANVISA PMDA TGA etc.) and adhere to corporate quality and compliance standards.
• Critically review and ensure consistency scientific accuracy and regulatory alignment of documents intended for worldwide submissions.
• Maintain compliant documentation and records that support post-marketing commitments and regulatory reporting obligations.

Regulatory Intelligence & Global Impact Assessment

• Conduct regulatory intelligence and monitor evolving global CMC regulatory requirements applicable to post-marketing products.
• Analyze and interpret changes in international regulations and provide recommendations on global impact to marketed products.
• Support due diligence and assessments of in-licensing candidates with a focus on CMC readiness and global lifecycle expectations.

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1