Associate Director, Oncology GRA

Role Summary

Associate Director, Global Regulatory Affairs (Oncology). Responsible for developing and executing global/regional regulatory strategies for assigned assets, ensuring alignment with Medicines Development Strategy and compliant with internal processes and regulatory requirements. Aims to deliver optimal labeling commensurate with available data and represents GSK with local regulatory agencies.

Responsibilities

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for development and delivery of regional regulatory strategies.
• Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure robust regulatory strategy supporting the development program and key markets.
• Work with local/regional commercial teams to secure labeling commensurate with data.
• Lead interactions with local/regional regulatory authorities.
• Proactively develop regional regulatory strategies that meet local 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‚Äôs 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 Qualifications

• Advanced Scientific Degree (PhD, MD, PharmD).
• Knowledge of all phases of the drug development process in regulatory affairs.
• Capability to lead regional development, submission, and approval activities in local region(s).
• Knowledge of clinical trial and licensing requirements in major countries in the region and ideally other key agency processes globally.
• Knowledge of relevant therapy area and ability to develop specialist knowledge for the product or area of medicine.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.