Posted Date:Sep 9 2022
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:
- 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 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. Be the EU agent (i.e. first point of contact for EMA) for one vaccine.
- Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents. Responsible for one or more specific sections.
- 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, for one or more sections
- 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.
- 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.
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.
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.
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
Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.