Regulatory Project Manager Lead
3 weeks ago
As a key member of our team at GlaxoSmithKline, you will play a vital role in ensuring the global regulatory compliance of our medicinal products. With your expertise in Chemistry, Manufacturing and Controls (CMC) regulatory affairs, you will be responsible for developing and implementing strategies to support late phase development and commercial lifecycle management activities.
Key Responsibilities:
- Develop and implement CMC regulatory strategies for assigned projects, ensuring compliance with applicable regulations and standards.
- Maintain high quality standards and continuous improvement, ensuring effective interaction with cross-functional teams.
- Ensure all appropriate CMC regulatory aspects are in place for product release, ensuring continuity of market supply.
- Engage in CMC Subject Matter Expert activities internally to enhance compliance, harmonisation, and efficiency.
About You:
- Bachelor's degree in life sciences or related scientific discipline.
- At least 5 years of experience in CMC regulatory affairs or product development, with direct involvement in regulatory submission preparation.
- Solid knowledge of drug development, manufacturing processes, and supply chain, with a specialized area of expertise.
- Estimated Salary: $85,000 - $110,000 per annum, depending on location and experience.
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