Senior Manager, Grl Delegate Therapeutic Vaccines
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Jul
As a Senior Manager, GRL delegate Therapeutic Vaccines you will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan.
This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Asset Profile, commensurate with the available data.
- This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following _
In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.
Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to ultimately secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data.
Lead interactions with local / regional regulatory authorities.In performing the role, the job holder will be responsible for:
- Proactively developing regulatory strategy, taking into account the needs of other regions globally.
- Implementation of the regional strategy(s) in support of the project globally
- Lead regulatory interactions and the review processes for assigned asset strategy
- Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable
- Ensuring compliance with global/ regional requirements at all stages of product life cycle.
- Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.
_ Why you?_
Basic Qualifications**:
- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor or higher degree preferred in biological or healthcare science
- Experience of all phases of the drug development process in Regulatory Affairs preferred
- Capable of leading regulatory development, submission, and approval activities in assigned region(s)
- Knowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
- Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
Preferred Qualifications:
- If you have the following characteristics, it would be a plus:_
- Good communication skills, especially written communications. Capable Skilled at delivering key communications effectively with clarity, impact, and passion
- Ability to foster strong matrix working and develops strong networks. Facilitates dialogue between team and matrix members to contribute their ideas.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Capable of developing and recommending strategies for change.
- Capable of identifying long term project or team issues in advance and seeking necessary help and support to resolve.
- Ability to take sound decisions and in doing so, will use a range of sources and weigh benefits and risks before making important decisions.
- Challenges and questions ways of working to seek improved processes. Seeks to raise levels of performance by establishing or improving processes.
_ 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-
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