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, aligning with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal processes and regulatory requirements, and delivering labelling commensurate with available data. Represents the company with local regulatory agencies and engages in matrix work at senior levels.

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 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 based on 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‚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 specialist knowledge for the product/area of medicine.
• Preferred: Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.

Skills

• Regulatory strategy development and execution
• Stakeholder management and matrix leadership
• Regulatory submissions and interactions with authorities
• Labelling and packaging considerations based on data
• Strategic thinking across regional and global contexts

Education

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

Additional Requirements

• No explicit travel requirements stated in the source.