Have you a passion to be part of cutting-edge science?
Do you have the drive and ambition to join a dynamic young fast-growing company?
Our client is a young exciting multinational biopharmaceutical company 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 to be based in their Dublin office.
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of the company’s drug development programs, policies, and procedures, so that the necessary state of compliance is maintained relative to all regulatory commitments. The position is particularly focused on supporting EU Regulatory Affairs.
Develop regulatory strategies for assigned programs in collaboration with the Exec Director for EU Regulatory Affairs by thorough research of guidance, EU precedents and emerging regulatory trends.
Management of all regulatory activities associated with specific EU tasks including but not limited to:
Participating in multidisciplinary study teams and in global regulatory strategy teams to provide regulatory guidance and communicate EU regulatory requirements.
Direct ownership of CTA submissions to multiple EU member states, including guiding teams on the content, format, style, and architecture of a CTA for EU studies.
Edit or manage the editing of the IMPD and other sections of a CTA against the regulatory requirements.
Manage the organization, preparation and review of CTA amendments, annual reports and other regulatory documents and correspondence.
Perform/manage critical analyses of data (clinical, preclinical, and manufacturing), independently developing interpretations and conclusions. Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.
Executing EU Scientific Advice requests including leadership of EMA and EU national agency meeting.
Work with Regulatory Operations to ensure appropriate planning, preparation, and submission of regulatory documentation.
Support internal readiness for the emerging Clinical Trial Regulations in Europe.
Continually monitor newly published EU Commission and EMA guidelines (and those from other countries geographically within the European region) in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
The Person Spec
- Advanced degree in a scientific discipline.
- Experience of direct filings of CTAs to EU national agencies is required, including management of voluntary harmonisation procedures.
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage.
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Excellent written and verbal communication skills.
- Comfortable speaking to and presenting scientific and clinical data.
- 5 years + prior experience in Regulatory Affairs in the biopharmaceutical industry
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