Associate Director, Oncology GRA

Role Summary

Associate Director of Global Regulatory Affairs responsible for developing and executing global and/or regional regulatory strategies for assigned assets, aligned with Medicines Development Strategy/Integrated Asset Plan and compliant with internal processes and regulatory requirements. Aims to deliver labelling that meets the Medicine Profile based on available data. Engages in extensive matrix work within the organization and represents 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 available data.
• Lead interactions with local/regional regulatory authorities.
• Proactively develop regulatory strategies that meet local region needs while considering global 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

• 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 all major countries in the region and, ideally, knowledge of other key Agency processes globally.
• Preferred: Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine.
• Preferred: Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.