Job Title: Associate Director, Regulatory Affairs EU – Oncology
Location: Dublin, Munich, or Amsterdam. (Hybrid)
Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)
Working for one of the industry’s most innovative biotechnology companies, this is a fantastic opportunity to provide expert regulatory knowledge to an early-stage development Oncology program focusing on the EU market.
This role will be responsible for leading/supporting the EU Regulatory Team across multiple geographies, providing support, mentorship, and advice in a challenging regulatory environment. You will have a sound understanding of the Oncology space, be able to devise strategies in line with business requirements globally and be able to influence at a high level internally and externally.
Responsibilities
· Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
· Build the representation of EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
· Assist Development teams and Regulatory senior management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
· Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
· Execute clinical trial applications for assigned programs and provide leadership for team members responsible.
· As needed, support activity with Business Partners to ensure the EU regulatory strategy meets business objective.
· Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
· Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
· Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
Job Requirements
• Advanced degree in a scientific discipline.
• 10+ years of regulatory experience with a focus on supporting products through clinical development.
• Ideally a background in Oncology or extensive experience working in this therapeutic area.
• Experience of managing and developing staff members desirable.
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
• Experience of providing EU regulatory strategy for Oncology is desirable.
• Experience of monoclonal antibodies is desirable.
• Experience of bringing a product through EU approval is a distinct advantage.
• Ability to negotiate and concisely express clear positions to stakeholders at all levels.
• Experience of directly working with national regulatory agencies and leading agency meetings face to face.
• Excellent written and verbal communication skills.
This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing Oncology portfolio. You will take the lead and work with senior board members across the globe to define regulatory / business strategy.
If you are interested in this role or would like more details please email your CV to [email protected]