Lead Oncology Labelling Strategist and Regulatory Expert
2 weeks ago
We are seeking a highly skilled Lead Oncology Labelling Strategist and Regulatory Expert to join our Global Regulatory Affairs (GRA) team at GSK.
As a key member of our GRA team, you will play a critical role in ensuring the accuracy and compliance of labelling for our oncology products. Your expertise will be instrumental in developing and implementing effective labelling strategies that meet regulatory requirements and support business objectives.
Key Responsibilities:- Develop and implement labelling strategies for oncology products, ensuring compliance with regulatory requirements and company policies.
- Collaborate with cross-functional teams, including clinical, safety, and regulatory experts, to ensure accurate and compliant labelling.
- Author and manage EU product information annexes for products registered via the EU centralized procedure.
- Manage documentation to support global and country/regional product information development and early maintenance.
- Interface with key labelling and governance stakeholders across GSK.
- Life sciences/pharmacy degree
- Relevant labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic area experience.
- Track record of authoring clear scientific labelling text for health professionals and patients.
- Fluency in English.
- A competitive salary: £85,000 - £105,000 per annum, depending on experience.
- An annual bonus based on company performance.
- Pension plan membership.
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