Senior Manager, GRL delegate Therapeutic Vaccines

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Site Name: Belgium-Wavre

Posted Date: Oct 8 2021

Job Purpose

You will have global responsibility (for Regulatory Affairs) of given activities for Therapeutic Vaccines Development within GSK Vaccines.

The Purpose Of The Job Is To

• Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines 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 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 or more specific section(s).
• Lead multidisciplinary teams focusing on meeting/delivering specific regulatory milestones/ documents (eg, briefing documents for agencies consultations, Paediatric Investigation Plan, IND, CTA,…).
• Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, etc.).
• Provide regulatory input for one or more 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.
• 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.
• May act as lead or N+1 within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team.
  

Key Responsibilities

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to Therapeutic vaccines development.
• You interact with (or represents his/her area/product at) internal multidisciplinary project related teams, for all parts of RA aspects of a given project top line and in depth on clinical/labelling.
• You lead multidisciplinary teams
• You participate to project/product-related discussions and provides strategic, scientific and RA input, for all parts of RA aspects of given project topline and in depth on clinical/labelling.
• You provide input into the asset specific regulatory strategy on a global scale.
• You provide support to the GRL via critical review of one or more specific sections of regulatory documents, internal and external.
• You may fulfil the role of N+1 review for regulatory documents.
• You provide input into the Global Regulatory Plan for one or more specific sections.
• You coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• You work with RA and non-RA stakeholders to ensure regulatory content is aligned with targeted overall profile of the product.
• You compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
• You provide input to Vaccines Development Plans in order to optimise submission strategy; accountable for Clinical RA aspects.
• You facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;
• You may act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
• 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).
• In collaboration with the relevant RA functions, as appropriate, you escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL.
• You must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
• You develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
• You ensure planning and proper organisation of activities in line with the overall project plan and RA milestones.
  

Why you?

Basic Qualifications

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

• Advanced Scientific Degree
• 6+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Experience in clinical regulatory affairs.
• Ability to lead, coordinate and execute regulatory strategy for a given project/product.
• Strategic thinker, creative mindset – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
• 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 to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
• Good influencing 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.
• Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• 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 vaccines and obtaining licenses in different geographical areas is preferred.
• Li-GSK
  

VxRD*

Why 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.

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

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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