Hobson Prior are working with a top pharmaceutical organisation who are looking for a Regulatory Submissions Team Lead to join them on a permanent basis Ireland.
Head up the Regulatory Affairs submission team.
Lead and manage the preparation of relevant documentation, ensuring submissions and deficiency questions are properly handled in timely manner with regards to new applications, renewal and variation procedures.
Maintain required databases, systems and processes.
Continually monitor new legislations.
Work collaboratively with other areas throughout the organisation.
Provide support to non-EU clients registration procedures.
Proofread and verify documents for precision and irregularities.
Capability to develop and manage high performing teams.
Strong problem-solving and analytical skills.
Understanding the scientific principles and regulatory requirements.
Strong communication skills, being fluent in both written and oral English.
Strong sense of planning, prioritization and ability to effectively manage projects.
Capacity to work effectively in a multicultural environment.
Education to MSc degree level or higher in a life science discipline.
At least 8 years of pharmaceutical (generics) industry experience.
Minimum 2 years management level experience.
Comprehensive knowledge of EU regulatory requirements with focus on Module 1 documentation and eCTD submissions.
Good understanding of requirements for new applications, variations and renewal processes in European procedures including MRP/DCP
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.