As a Senior Manager Regulatory Affairs, GRL Delegate, you will have global responsibility (for Regulatory Affairs) for the development and lifecycle activities related to pneumococcal vaccines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

The role includes the following responsibilities:

• Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to vaccines registration and lifecycle management.
• 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.
• Lead multidisciplinary teams
• 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.

• Provide input into the asset specific regulatory strategy on a global scale.
• Provide support to the GRL via critical review of one or more specific sections of regulatory documents, internal and external.
• Provide input into the Global Regulatory Plan for one or more specific sections.
• Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• Work with RA and non-RA stakeholders to ensure regulatory content is aligned with targeted overall profile of the product.
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
• Provide input to Vaccines Development Plans in order to optimise submission strategy; accountable for Clinical RA aspects.
• Facilitate and deliver the regulatory strategy to support the registration and lifecycle of the asset;
• 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, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL.
• Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
• 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.
• 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:

• Ph.D. or M.D Pharmacy, Chemistry, Biology or Medicine

• Senior Global Regulatory Manager: 6+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Previous experience in the development/ registration/lifecycle management of vaccines and obtaining licenses in different geographical areas is preferred.
• Experience in managing teams and leading in a matrix organization.
• Ability to lead, coordinate and execute regulatory strategy for a given project/product.

Preferred Qualifications:

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

• 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.
• In collaboration with relevant multidisciplinary stakeholders, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

• Li-GSK

#VaccinesRD

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.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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