Regulatory Affairs Associate Director
il y a 1 semaine
Site Name:
Belgium-Wavre, Baar Onyx, GSK House, Italy - Siena
Posted Date:
May
The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.
The purpose of this team is to 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.
Responsibilities and Accountabilities:
You are accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans.
In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) 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 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, you will be responsible for:
- Proactively developing regulatory strategy, considering 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?
Experience, Skills and Specialized Knowledge Required
- Degree in biological or healthcare science
- Experience in Early activities and launch of Phase I and II, 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
Competencies and Capabilities:
- 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.
GSKVaccines
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.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for pa-
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