Associate Director - Regulatory Affairs, Oncology

4w1 month ago

GSK

US · Full-time · $138,750 – $231,250

About this role

At GSK, we aim to positively impact the health of 2.5 billion people. This role ensures the development of appropriate global and regional regulatory strategies for oncology assets, consistent with the Medicines Development Strategy and Integrated Asset Plan.

Proactively develop and implement regional regulatory strategies that deliver the needs of local regions while aligning with global requirements. Lead regulatory interactions with local authorities to ensure compliance with GSK processes and regulatory requirements.

Work closely with global/regional counterparts and commercial teams to secure best possible labeling commensurate with available data. Accountable to the Global Regulatory Lead and Global Regulatory TA Head, the role requires extensive matrix working within GSK up to VP level.

Shape regulatory strategy for transformational oncology medicines and influence development programs to deliver best possible labeling. Represent GSK with local regulatory agencies, uniting science, technology and talent to get ahead of disease together.

Requirements

Experience of all phases of the drug development process in regulatory affairs.
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 knowledge of other key Agency processes globally.
Proactive problem-solving skills to identify and resolve project or team issues in advance.
Creative regulatory problem-solving skills.

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 in support of the project globally.
Lead regulatory interactions and review processes in the local region.
Ensure appropriate interaction with global/regional counterparts and commercial teams in the local region.
Ensure compliance with global and regional requirements at all stages of product life.
Assess precedent, regulatory intelligence, and competitive environment from a regulatory perspective for the region.
Work closely with the Early/Medicine Development Team to ensure a robust regulatory strategy supports the development program.