Global Regulatory Affairs Manager

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Job Title

Global Regulatory Affairs Manager

In this role you will…

• Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
• Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one specific (clinical/labelling or technical/NC or procedural) section.
• Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labelling or t/NC or procedural).
• Provide regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio.
• Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for a specific section (clinical/labelling or technical/NC or procedural).
• Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
  

The GRA Manager will be part of a global team working to define the world-wide regulatory strategy for key assets in the vaccine pipeline. We support Research and Development teams as well the commercial vaccine strategy by contributing with regulatory expertise, engagement, and patient focus to drive the lifecycle management and new marketing authorization opportunities.

This job opportunity is also open for relocation.

Why you? 

Qualifications & Skills: 

• Master’s Degree or PhD in scientific discipline 
• 4+ years significant experience in regulatory affairs
• English proficiency
• Ability to coordinate and execute regulatory strategy for a given project/product.
• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
  

Preferred Qualifications & Skills

• Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
• Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Good influencing skills.
• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
• Quality mindset
  

Inclusion & Diversity At GSK

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.

GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (contact email) to further discuss this today.

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