Associate Director, Global Regulatory Affairs, Oncology

We have exciting career opportunities in Global Regulatory Affairs for Manager level individual strategic contributors to support exciting and innovative research across the Oncology therapies. We have been actively exploring ways to help, with our science and expertise, alongside protecting the health and wellbeing of our people and managing our global supply chains to support patients and consumers who depend on our products.

This represents an exciting opportunity to be part of GSK Pharma R&D, who is committed to innovative scientific research and discovery to help people do more, feel better, live longer. In this role, you will provide regulatory strategic leadership and support for early and/or late-stage Pharmaceutical R&D portfolio.

Our Global Regulatory Affairs (GRA) Therapeutic Group (part of the Global Regulatory and Quality organization in Pharmaceutical R&D) develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with Pharmaceutical R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK.

We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders.

Purpose

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

Accountable to GRL and Global Regulatory TA Head 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 level and representing GSK with at least the local regulatory agency. 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. Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:

• 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 globally Lead regulatory interactions and the review processes in local region
  
• 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
  
• 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 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.
  

Why You

Basic Qualifications:

• Bachelor's degree or preferably PhD in biological or healthcare science
  
• 5 years' Experience of all phases of the drug development process in regulatory affairs preferred
  
• 5 years' experience of leading regional development or global, submission and approval activities in local region(s)
  
• 5 years' Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
  

Preferred Qualifications:

• Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
  
• Minimum 5+ years of global regulatory experience in drug development and life-cycle management. Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
  
• Demonstrated leadership capabilities and ability to think strategically
  
• Demonstrated ability to integrate regulatory science with scientific/clinical knowledge
  
• Demonstrated track record of working in a global team and matrix organization
  
• Demonstrated negotiation skills across levels within an organization and with external stakeholders
  
• Experience in managing multiple projects and proactively plan
  

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 get Ahead Together.

#LI-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 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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