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CMC Regulatory Expert

1 tydzień temu


Poznań, Greater Poland TN Poland Pełny etat

About the Company:

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies.

Your Key Responsibilities:

  1. Work closely with the New Registration CMC Team to develop and implement regulatory strategies;
  2. Author and compile regulatory submissions for new chemical entities and product expansions;
  3. Collaborate with cross-functional teams to ensure regulatory requirements are met;
  4. Develop and maintain relationships with regulatory agencies;
  5. Stay up-to-date with regulatory changes and implement process improvements;
  6. Communicate effectively with internal stakeholders and provide training on regulatory matters;
  7. Lead projects and initiatives to improve regulatory processes and efficiency.

About Our Requirements:

To be successful in this role, you will need extensive experience in regulatory affairs, preferably in the pharmaceutical industry. A Bachelor's or Master's degree in biotechnology, pharmacy, chemistry, or other related science or technical field is required.

You should have excellent written and verbal English language communication skills, adaptability, and a commitment to ongoing professional development. Experience with Veeva Vault would be an asset.