Associate Director, Oncology GRA

Role Summary

As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal processes and policy as well as appropriate regulatory requirements. The ultimate goal is to deliver the best possible labelling that meets the Medicine Profile, commensurate with the available data. You will engage in extensive matrix working within the organization up to the VP level and represent the company with local regulatory agencies.

Responsibilities

• Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to plans.
• Collaborate with the Early/Medicine Development Team (EDT/MDT) or GRL to ensure a robust regulatory strategy is in place to support the development program and meet the needs of key markets.
• 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 the needs of the local region(s), while considering the needs of other regions globally. 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 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.

Skills

• Regulatory strategy development and execution
• Global/regional regulatory compliance
• Stakeholder engagement and matrix leadership
• Labelling negotiation and optimization
• Regulatory authority interactions

Education

• Bachelor’s degree in biological or healthcare science.
• Advanced degree (PhD, MD, PharmD) preferred.