GRL delegate, Manager, Global Regulatory Affairs

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Site Name: Belgium-Wavre

Posted Date: May 25 2022

As Manager Glocal Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for RSV OA (regional) within GSK Vaccines.

Key Responsibilities

• You provide support to the Global Regulatory Lead (GRL) for key regulatory activities
• You interact with internal project related teams (e.g. CRT, SRT, etc.) and possibly project teams (PTs), for clinical/labelling or procedural aspects
• You participate to project/product-related discussions and provide in-depth strategic, scientific and RA input, for clinical/labelling or procedural aspects
• You provide in-depth input into the asset specific regulatory strategy on a global scale for clinical/labelling or procedural aspects
• You provide support to the GRL via critical review of the clinical/labelling or procedural section of regulatory documents, e.g. Global regulatory Plan etc.
• You may fulfil the role of review for clinical/labelling or technical/NC or procedural-based documents
• You provide in-depth input on clinical/labelling or procedural aspects/sections of the Global Regulatory Strategy (GRS)
• You coordinate (for one specific clinical/labelling or procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• You compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or procedural sections) and ensure that those documents meet regulatory requirements
• You provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of clinical/labelling or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or procedural aspects
• You facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
• You may possibly 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
• 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 within the remits of his/her expertise area (clinical/labelling and/or procedural)
• You must be aware of changes in regulatory guidelines and their impact on regulatory strategy
• You develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities
• You ensure planning and proper organization of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones
• You work in high performing matrix teams with the different GRA groups and beyond, to ensure alignment to 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: General Science or Life Science)
• Previous experience in regulatory affairs within industry is required to ensure appropriate level of understanding of the RA activities and impact
• 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, maximize 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
  

Preferred Qualifications

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

• Ph. D. or M.D. (Pharmacy, Chemistry, Biology or Medicine)
• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred
  

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.

• Li-GSK
  

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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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