The Director of Regulatory Affairs-Oncology will be accountable to the GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting this 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. The role will work closely with local / regional commercial teams to secure best possible... more details
The Director of Regulatory Affairs-Oncology will be accountable to the GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting this 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. The role will work closely with local / regional commercial teams to secure best possible labelling commensurate with the available data. Will also lead interactions with local / regional regulatory authorities.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Key Responsibilities:
Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
Implement the regional strategy(s) in support of the project globally.
Lead regulatory interactions and the review processes in local region.
Ensure appropriate interaction with regional commercial teams in local region.
Ensure compliance with regional requirements at all stages of product life from C2MD.
Advocate persuasively approaches to senior leaders in GSK and in Health Authorities
Provide assessments of potential in license molecules.
Why You?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS degree in a biological or healthcare science.
Experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
Experience of leading regional development, submission, and approval activities in local region(s). Experience organizing and executing milestone meetings. Experience with clinical trial and licensing requirements in all major countries in the region.
Oncology Experience required with the regulatory affairs space.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project. Developing an external network
Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions.
Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
Business Skills
Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques.
Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 prevent and treat disease with vaccines, specialty and general medicines. 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 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.
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