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Strategic Oncology Regulatory Lead
1 month ago
GSK is seeking a highly skilled Global Regulatory Affairs Director to join our team in the UK.
About GSK
We have bold ambitions for patients, aiming to positively impact health. Our R&D team is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Job Description:
- Act as the Global Regulatory Lead (GRL) or collaborate with the GRL and Global Regulatory Therapeutic Area (TA) Head to develop and implement robust regional regulatory strategies.
- Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies.
- Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.
- Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
- Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies.
Required Skills and Qualifications:
- Bachelor's degree in biological or healthcare science.
- Extensive experience in pharmaceutical industry Regulatory Affairs.
- Ability to develop necessary specialist knowledge for the product in a specific oncology disease area.
- Advanced Scientific Degree (PhD, MD, PharmD).
- Knowledge of the drug development process in regulatory affairs.
- Awareness of global regulatory processes, including submission and approval activities.
- Creative problem-solving abilities with a balanced approach to regulatory expectations and compliance.
Salary and Benefits:
The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience. We offer a comprehensive benefits package, including a pension scheme, life insurance, and access to our employee assistance programme.
About the Role:
This is an exciting opportunity to work with a talented team and contribute to the development of innovative medicines. If you are passionate about regulatory strategy and oncology, we encourage you to apply.
