Associate Regulatory Program Director - CMC/Health Authority

Roche; Mississauga; On-site; CAD 115,000 - 151,000; Full time

Job summary

Roche in Mississauga seeks an Associate Regulatory Program Director in Pharma Technical Regulatory to lead CMC submissions to global health authorities and drive regulatory strategies across the product lifecycle.

You will partner with multiple stakeholders to ensure data integrity in regulatory information management systems and deliver timely, compliant regulatory documents. A background in biologics or related areas is a plus; relocation is not offered.

Qualifications

• Bachelor's Degree in life science disciplines.
• Minimum 5 years of industry experience in technical regulatory CMC.
• Experience developing global regulatory strategies and scenario planning with risk assessment.
• Knowledge of global Health Authority guidelines and interactions with health authorities.
• Technical understanding of drug substance, manufacturing, CQAs, control systems, changes and comparability.
• Knowledge of multidisciplinary functions involved in drug development and product lifecycle.

Responsibilities

• Submit high-quality CMC regulatory documents to health authorities globally per cGMP and Roche standards.
• Develop, communicate and execute robust regulatory strategies aligned with global requirements.
• Ensure data accuracy in regulatory information management systems and cross-functional deliverables.
• Contribute to regulatory excellence and timely regulatory approvals by identifying risks and improvements.
• Understand regulator structures, guidelines and support processes to improve best practices.

Education

Bachelor's degree in life sciences

Tools

Regulatory information management systems

Job description

Roche in Mississauga seeks an Associate Regulatory Program Director in Pharma Technical Regulatory to lead CMC submissions to global health authorities and drive regulatory strategies across the product lifecycle.

You will partner with multiple stakeholders to ensure data integrity in regulatory information management systems and deliver timely, compliant regulatory documents. A background in biologics or related areas is a plus; relocation is not offered.