Senior Regulatory Affairs Strategist
1 month ago
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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Regulatory Affairs Director
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Stevenage, Hertfordshire, United Kingdom GSK Full timeJob DescriptionGSK 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 are currently seeking a Regulatory Affairs Director - CMC to join our team in the UK. The successful candidate will have a strong...
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Global Regulatory Affairs Director
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Director of Regulatory Affairs
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CMC Regulatory Manager
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Senior Manager, CMC Regulatory Affairs
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Regulatory Affairs Director, Gene Therapy
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Senior Director, Biologics Regulatory CMC
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