Our client is a young exciting multinational biopharmaceutical company known for its scientific and operational excellence enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a management position in Regulatory Affairs clinical development to be based in their Dublin office
The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin office. The role is positioned at the Manager/Senior Manager level to enable advanced regulatory input to interactions with EU Regulatory agencies and with our business partners.
- Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.
- Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
- Assist clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
- Provide leadership on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
- 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).
- Build the representation of company's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
- Further build company’s regulatory profile in the EU, serve as a resource for EU knowledge for the global regulatory and development teams.
- Conduct those activities as deemed necessary under the leadership of the Director of Regulatory Affairs to support program progression.
- Advanced degree in a scientific discipline.
- 5+ years regulatory experience with a focus on supporting products through clinical development, and in the post approval setting.
- Experience of life-cycle management of approved products in the centralised procedure a distinct advantage.
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.
- Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
- 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.
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