Manager, Global Regulatory Affairs

You will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines.

The purpose of the job is to:

• 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/nonclinical (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

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.

• You interact with internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs), for clinical/labelling or technical/CMC or procedural aspects of a given project.

• You participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of given project.

• You provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or technical/NC or procedural aspects.

• You provide support to the GRL via critical review of the clinical/labelling or technical/NC or procedural section of regulatory documents, GRPs and KMSs.

• You provide in-depth input on clinical/labelling or technical/NC or procedural aspects/sections of the Global Regulatory Plan (GRP).

• You coordinate (for one specific clinical/labelling or technical/NC or procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL

• You compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or technical/NC or procedural sections) and ensure that those documents meet regulatory requirements.

• You provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC or clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects.

• You facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects

• You provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s)

• You ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Advanced Scientific Degree

• 4+ years significant experience in regulatory affairs, or appropriate relevant experience. Broad knowledge is required and covers scientific as well as regulatory expertise.

• Ability to coordinate and execute regulatory strategy for a given project/product.

• Strategic thinker

• Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence

• Good presentation skills

• Culturally aware.

• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner

• Ability to resolve problems through resourceful use of information and contacts.

• Quality mindset

• Fluent in English, with excellent writing skills.

• Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ph.D. or M.D

• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.

• Li-GSK

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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