Associate Director, Oncology GRA

Role Summary

Associate Director, Oncology GRA will ensure the development and execution of global and/or regional regulatory strategies for assigned assets, aligned with the Medicines Development Strategy/Integrated Asset Plan and compliant with internal processes and regulatory requirements. The role aims to deliver labelling commensurate with available data and engage in extensive matrix collaboration within GSK up to the VP level, representing GSK with local regulatory agencies.

Responsibilities

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for developing and delivering appropriate regional regulatory strategies according to plans.
• Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy supports the development program and meets key market needs.
• Work closely with local/regional commercial teams to secure the best possible labelling commensurate with the data.
• Lead interactions with local/regional regulatory authorities.
• Proactively develop regulatory strategies that meet local needs while considering global region needs; implement regional strategies in support of global projects.
• Ensure compliance with global/regional requirements at all stages of the product life cycle.

Qualifications

• Required: Bachelor’s degree in biological or healthcare science.
• Required: Minimum 2 years of Regulatory Affairs experience including interaction with regulatory bodies.
• Required: Experience managing development, submission, and approval activities in different regions globally.
• Required: Experience in Oncology disease area.
• Preferred: Advanced Scientific Degree (PhD, MD, PharmD).
• Preferred: Knowledge of all phases of the drug development process in regulatory affairs.
• Preferred: Capability to lead regional development, submission, and approval activities in local region(s).
• Preferred: Knowledge of clinical trial and licensing requirements in major countries in the region and ideally other key Agency processes globally.
• Preferred: Knowledge of relevant therapy area and the ability to develop specialist knowledge for the product or area of medicine.
• Preferred: Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.

Education

• Bachelor’s degree in biological or healthcare science (required).