Description:
Our client is a young exciting multinational biopharmaceutical company, known for its scientific and operational excellence. The company is enjoying exceptional growth, combined with a strong high potential pipeline, which has led to an internal promotion.
The appointment of a high performing Regulatory Affairs Director (based in their Dublin office) is designed to meet the growing need for EU-specific expertise on their development programs as well as to keep the company compliant on emerging EU legislation and processes.
Job Spec
The role is positioned at the Director level to enable independent working and leadership in direct interactions with EU Regulatory agencies and with business partners. This role will be focussed on supporting development activities for oncology programs with ongoing activities in phase 1 through phase 3 and the post-marketing setting.
- Where required, lead 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 the company’s 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 company’s 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 the need arises.
- Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
- Experience of managing and developing staff members desirable.
- Proven track record supporting EU Clinical Trial Applications through approval and study start up.
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
- 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 directly working with national regulatory agencies / leading agency meetings face to face.
- Excellent written and verbal communication skills.