Regulatory Affairs Manager / Associate Director

We are seeking a talented Regulatory Affairs professional to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team.

The Manager / Associate Director ensures the development of appropriate global and regional regulatory strategies and their execution for assigned assets to ensure the development program meets the needs of the key markets identified and the Medicines Profile.

Key Responsibilities:

• Proactively develop regulatory strategies that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Manage regulatory interactions and the review processes in local regions.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure compliance with global/regional requirements at all stages of product life.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.

Requirements:

• Degree-educated in relevant scientific or technical discipline.
• Relevant regulatory affairs experience in the EU and/or US and other major markets.
• Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
• Ability to develop necessary specialist knowledge for the product or area of medicine.
• Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.

Preferred Qualifications:

• Experience of all phases of the drug development process in regulatory affairs.
• Knowledge of clinical trial and licensing requirements in all major countries in the region.
• Experience in relevant therapy area (especially Immunology & Inflammation) is a plus.

Location: The successful applicant can be based at GSK HQ (London), Wavre (Belgium) or Upper Providence, Durham or Rockville (USA).

Salary:

• London: £89,250 to £148,750 per annum
• Belgium: EUR 89,250 to EUR 148,750 per annum
• USA: $138,600 to $231,000 per annum