Associate Director, Oncology GRA

Role Summary

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

Responsibilities

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (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 supporting the development program and key markets.
• Work with local/regional commercial teams to secure the best possible labelling from the data available.
• Lead interactions with local/regional regulatory authorities.
• Develop 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: 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 ability to develop necessary specialist knowledge for the product or area of medicine.
• Preferred: Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.

Skills

• Regulatory strategy development and execution
• Stakeholder management and cross-functional collaboration
• Regulatory authority engagement and submission activities
• Labelling negotiation and optimization
• Knowledge of oncology regulatory pathways

Education

• Bachelor‚Äôs degree in biological or healthcare science
• Advanced degree preferred: PhD, MD, or PharmD

Additional Requirements

• Travel and relocation not specified as essential in the description.