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Associate Director Regulatory Affairs, Oncology
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
This role will 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.
Key Responsibilities:
• Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Lead regulatory interactions and review processes in local region.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure 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.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Experience of all phases of the drug development process in regulatory affairs preferred.
Experience leading regional development, submission and approval activities in local region(s).
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 & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
• Advanced Scientific Degree (PhD, MD, PharmD).
• Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs.
• Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Ability to develop networks within GSK to secure support and achieve project outcomes.
#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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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