Senior Regulatory Affairs Strategist

1 month ago


Stevenage, Hertfordshire, United Kingdom GSK Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Strategist to join our team at GSK. As a key member of our Regulatory Affairs department, you will play a critical role in shaping the development and implementation of our regulatory strategy for pharmaceutical products.

This is an exciting opportunity for a talented individual with a strong background in regulatory affairs and experience in managing complex worldwide CMC regulatory requirements. You will work closely with cross-functional teams to ensure compliance with evolving regulatory requirements and identify risks to the business associated with submission data and information packages.

The ideal candidate will have a Bachelor's Degree in Life Sciences or related discipline and proven project management and multi-tasking skills. Experience in drug development and manufacturing processes is also essential.

As a Senior Regulatory Affairs Strategist, you will be responsible for:

  • Developing and implementing CMC regulatory strategies to support product submissions and lifecycle maintenance
  • Coordinating the preparation of technical (CMC) regulatory documents and ensuring compliance with regulations
  • Mentoring and training staff on regulatory procedures and best practices

In return, we offer a competitive salary of $120,000 - $180,000 per annum, depending on experience, plus benefits including health insurance, retirement plan membership, and shares and savings program.



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