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:
1. Reporting to the Head of Quality, this is a client and regulatory agency facing role.
2. 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.
3. Preparation, review and approval of client regulatory deliverables.
4. Develop the regulatory strategy to support registration and/or renewal.
5. Collaborate with colleagues across the business and in external companies to identify data requirements for product registration/renewal.
6. Report on project progress.
7. Monitor the progress of the evaluation and ensure all regulatory queries are addressed in a timely fashion.
8. Be subject matter expert (SME) on the legislation and guidelines in the territory/territories which you are assigned to work in.
9. Collaborate with the team members at relevant meetings and proactively communicate with the team members and/or departments on issues.
10. Development & ongoing evaluation of regulatory training programme and training delivery.
11. Assist with project management of regulatory activities and proactively identify & implement improvement projects.
Experience & Qualifications
Essential
1. Primary Degree in scientific discipline or equivalent.
2. Relevant post-graduate qualification an advantage Regulatory professional with minimum 3 years' experience in Pharma/Biotech Regulatory Affairs.
3. Knowledge of regulatory frameworks for advanced therapies.
4. Experience in responding to health authority queries.
5. Demonstrated ability to operate within cross-functional teams.
6. Effective organisational skills and ability to work independently.
7. Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic.
8. Excellent attention to detail is essential for this role.
9. Excellent project management & organisational skills with the ability to multi-task and work in an environment with shifting priorities.
10. Strong written and verbal communication skills with the ability to liaise with regulatory authorities and internal stakeholders.
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