I'm currently hiring a Reg Affairs Specialist for one of our top clients in Dublin.
This company is growing rapidly and now is a great time to join.
Permanent role, full time on site for the first 6 months. Principal Responsibilities: Reporting to the Head of Quality, this is a client and regulatory agency facing role.Ownership of client regulatory projects, working within a team of SMEs to deliver a regulatory roadmap for client projects including new products and variations to existing filings.Preparation, review and approval of client regulatory deliverables.Develop the regulatory strategy to support registration and/or renewal.Collaborate with colleagues across the business and in external companies to identify data requirements for product registration/renewal.Report on project progress.Monitor the progress of the evaluation and ensure all regulatory queries are addressed in a timely fashion.Be subject matter expert (SME) on the legislation and guidelines in the territory/territories which you are assigned to work in.Collaborate with the team members at relevant meetings and proactively communicate with the team members and/or departments on issues.Development & ongoing evaluation of regulatory training programme and training delivery.Assist with project management of regulatory activities and proactively identify & implement improvement projects.Experience & Qualifications Essential Primary Degree in scientific discipline or equivalent.Relevant post-graduate qualification an advantage Regulatory professional with minimum 3 years' experience in Pharma/Biotech Regulatory Affairs.Knowledge of regulatory frameworks for advanced therapies.Experience in responding to health authority queries.Demonstrated ability to operate within cross-functional teams.Effective organisational skills and ability to work independently.Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic.Excellent attention to detail is essential for this role.Excellent project management & organisational skills with the ability to multi-task and work in an environment with shifting priorities.Strong written and verbal communication skills with the ability to liaise with regulatory authorities and internal stakeholders.
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