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.
