Principle Registration Officer - Life Science - London
Are you looking for the opportunity to work alongside a global pharmaceutical organization in Ireland’s picturesque capital? Our esteemed client is seeking a Regulatory Officer to join their team at their manufacturing facility in North Dublin.
The facility is responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottles, primarily for tablets and capsules). Our client needs a Regulatory Officer to help maintain manufacturing operations.
Responsibilities:
1. Obtain and maintain generic and branded marketing authorizations for designated EU and non-EU territories to ensure on-time launches, continued supply, and compliance of all products.
2. Manage and coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, and liaising directly with agencies as a Subject Matter Expert.
3. Maintain databases and systems in accordance with current SOPs to fulfill regulatory obligations.
4. Advise senior management on the status and progress of projects to meet departmental and regional objectives and timelines; identify potential problems or delays and propose solutions.
5. Stay informed about regulatory requirements, including legislation, guidelines, industry best practices, and liaise with competent authorities.
6. Provide expertise and support to the department, including mentoring and training in specialist areas as required.
7. Participate in Principal Registration Officer meetings, proactively raise issues, collaborate on solutions, and ensure dissemination of decisions to junior team members.
Requirements:
1. BSc in Life Sciences or higher qualifications.
2. Extensive proven experience in EU Regulatory Affairs as a Subject Matter Expert.
3. At least 5 years of experience with the full lifecycle of product registrations, including strategy, planning, registration, monitoring, post-marketing approvals, and product launch in accordance with EU regulations.
4. In-depth understanding of DCP / MRP processes, with examples of estimating approval times and handling variations and submissions.
5. Effective verbal and written communication skills.
6. Experience managing large, fast-paced product portfolios.
7. Flexible approach to prioritize tasks according to company needs.
8. Previous experience mentoring junior staff, including SROs & ROs.
If this role interests you, please apply now!
Please note that if you are not a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.
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Created on 22/06/2025 by TN United Kingdom
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