Project Manager, CMC Regulatory Affairs Specialist

2 weeks ago

Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time
Job Summary

We are seeking a highly skilled Project Manager, CMC Regulatory Affairs to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs team, you will be responsible for leading CMC regulatory activities across various projects, ensuring compliance with global regulatory requirements and standards.

Key Responsibilities:
  • Develop and implement CMC regulatory strategies for assigned projects, ensuring timely and effective submission of regulatory documents.
  • Collaborate with cross-functional teams to ensure seamless integration of CMC regulatory activities with other project aspects.
  • Provide expert guidance on CMC regulatory requirements and standards, ensuring compliance and adherence to company policies.
  • Manage and maintain accurate records of CMC regulatory submissions, ensuring easy access and retrieval of information.
  • Stay up-to-date with changing regulatory landscapes and emerging trends, applying this knowledge to inform CMC regulatory strategies and activities.
Requirements:
  • Bachelor's degree in a Life Sciences or related field.
  • Minimum 2 years of experience in CMC regulatory affairs or product development, with a focus on regulatory submission preparation.
  • Strong understanding of CMC regulatory requirements and standards, including experience with IND/IMPD, NDA/BLA/MAA submissions.
  • Excellent communication and project management skills, with the ability to work effectively in a fast-paced environment.
Preferred Qualifications:
  • Master's degree in a Life Sciences or related field.
  • RAPS Certification.
  • Experience with biologics and Veeva Vault.
  • Pre-approval experience, including phase 1 to phase 3 submission experience.

We offer a comprehensive benefits program and a dynamic work environment that fosters growth and development. If you are a motivated and detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles. We are committed to creating an inclusive and diverse workplace that values and respects all employees.

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