As GRA Manager you will be responsible to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. 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 Medicine Profile, commensurate with the available data.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. In this role, you will be a ccountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. In performing the role, the job holder will be responsible for:
Why you? Basic Qualifications:
- Proactively developing regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategy(s) in support of the project
- Ensuring appropriate interaction with global/regional counterparts and commercial teams in local region
- Ensuring compliance with global/ regional requirements at all stages of product life
- Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree or preferably PhD in biological or healthcare science
- Experience of all phases of the drug development process in regulatory affairs preferred
- Experienced in clinical trial and licensing requirements in all major countries in the region
- Experienced in relevant therapy area
If you have the following characteristics, it would be a plus:
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact, and passion
- Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly
- Ability to foster strong matrix way of working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognizes potential long-term issues for projects
- Ability to make sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions. Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process
- Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project
- Ability to further develop necessary specialist knowledge for the product or area of medicine.
- ideally knowledge of other key Agency processes globally
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead 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. 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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