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Associate Director, Regulatory Affairs – Oncology

Leinster   •  Negotiable  •  Permanent, Full time

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.


· 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 lucy.kirkaldy@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2309-522879
  • Posted: 18th September 2023
  • Expires: 16th October 2023

Cpl Life Sciences

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