Submission Lead – Regulatory Affairs

Elevate your regulatory career with GSK as a Submission Lead, playing a pivotal role in regulatory compliance. This hybrid role offers flexibility while working in Mississauga, Ontario.

In the role of a Regulatory Submission Lead, you will manage submission activities for assigned dossiers and ensure alignment with both local and global regulations. This position requires your in-depth knowledge of regulatory processes and collaboration with various teams. You'll effectively contribute to improving healthcare accessibility through high-quality, compliant submissions.

Key Responsibilities:

• Ensure timely delivery of regulatory submissions under tight deadlines
• Independently assess data for compliance with EU, US, and ROW requirements
• Engage with regulatory agencies to address issues
• Provide training on regulatory processes to team members
• Conduct scenario planning for regulatory strategies

Requirements

• 5 years of expertise in drug development processes
• Familiarity with CMC content requirements preferred
• Advanced degree or relevant certification is a plus
• Strong interpersonal and communication skills
• Adaptable in a matrixed work environment

Drive innovation in regulatory submissions and enhance global health outcomes with GSK.

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