GRL delegate/ Senior Manager Clinical Regulatory Affairs

Jobinhalt

Site Name: Belgium-Wavre

Posted Date: Oct 6 2022

As a GRL delegate/ Senior Manager Clinical Regulatory Affairs, you will be responsible for:

• Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for early development 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 (clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. CTA/IND, Q&A, scientific consultations, Paediatric Investigational Plans, PSP, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one or more specific (clinical/labelling and/or procedural) section(s).
• 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 or more specific sections (clinical/labelling and/or procedural).
• 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 (clinical/labelling and/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.
  

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 a project/product.
• Interact with (or represents his/her area/product at) internal project related teams (e.g. CRT, SRT etc.) and possibly project teams (PTs), for all parts of RA aspects of a given project top line and in depth on clinical/labelling or technical/NC or procedural aspects.
• 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 or technical or procedural aspects.
• 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 (clinical/labelling and/or technical/NC and/or procedural) of regulatory documents, GRPs and KMSs.
• May fulfil the role of N+1 review as per RSBP.
• 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 (clinical/labelling and/or procedural) 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 technical/NC and/or procedural and accountable for one of the RA aspects.
• May act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
• 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 (for one or more of RA specific activities within clinical/labelling or technical/NC or procedural) 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:

• Bachelor’s Degree.
• More than 6 years of experience in regulatory affairs.
• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas.
  

Preferred Qualifications

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

• Ability to coordinate and execute regulatory strategy for a given project/product.
• Strategic thinker – 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 the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

#VaccinesRD

• Li-GSK
  

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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