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

The purpose of the job is to:

Your responsibilities:

• Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
• Interact with (or represents his/her area/product at) internal project related teams (e.g. LTT, SRT etc.) and possibly project teams (PTs).
• Participate to project/product-related discussions and provides strategic, scientific and RA input.
• 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 and internal documents (e.g. Global regulatory Plan, Key Message Summary).
• May fulfil the role of N+1 for the review of some document.
• Provide input into the Global Regulatory Plan (GRP) for one or more specific (clinical/labelling and/or procedural) sections
• Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product.
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling and/or procedural) and ensure that those documents meet regulatory requirements.
• Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical/NC, clinical/labelling and use of appropriate regulatory procedures to secure the optimum submission strategy; contributes for clinical/labelling and/or procedural and accountable for one of the RA aspects.
• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and procedural and accountable for one or several of the RA aspects.
• May act as the point of contact for Regulatory Agencies for asset(s) (e.g. project-specific EU agent)
• 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:

• 6+ years significant experience in regulatory affairs, or appropriate relevant experience

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

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

• 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

• Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.

• 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 the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.

Preferred Qualifications:

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

• Broad knowledge is required and covers scientific as well as regulatory expertise

• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy

• Good influencing skills

• Culturally aware

• Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.

• Li-GSK

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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

• This is a job description to aide in the job posting, but does not include all job evaluation details.

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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