Associate Director, Oncology GRA

Role Summary

Associate Director, Global Regulatory Affairs (Oncology). Responsible for development and execution of global and regional regulatory strategies for assigned assets, ensuring alignment with Medicines Development Strategy/Integrated Asset Plan and compliance with internal processes and regulatory requirements. Aims to deliver optimal labelling commensurate with available data.

Responsibilities

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

Qualifications

• 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 (Required).

Skills

• Regulatory strategy development for multiple regions.
• Regulatory submissions and approvals across global regions.
• Communication and stakeholder management with regulatory authorities and internal teams.

Education

• Bachelor‚Äôs degree in biological or healthcare science (Required).
• Advanced Scientific Degree (PhD, MD, PharmD) (Preferred).

Additional Requirements

• Knowledge of drug development processes in regulatory affairs across major countries/regions (Preferred).
• Capability to lead regional development, submission, and approval activities (Preferred).
• Ability to navigate clinical trial and licensing requirements in major regional jurisdictions (Preferred).
• Knowledge of therapy area and development of specialist knowledge for the product (Preferred).
• Creative regulatory problem-solving abilities balancing agency expectations and compliance (Preferred).