Principle Registration Officer - Life Science - London
Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland’s picturesque capital? Our esteemed client is looking for a Reg Officer to join their team in their existing manufacturing facility in North Dublin.
The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Reg Officer to help maintain manufacturing operations.
Responsibilities:
1. Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply and the compliance of all products.
2. Manage & coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, liaising directly with Agencies as Subject Matter Expert.
3. Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
4. Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
5. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
6. Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
7. Attend and contribute at Principal Registration Officer meetings; proactively raise issues and collaborate effectively to propose solutions. Ensure company/regulatory decisions are disseminated to junior team members.
Requirements:
8. BSc in Life sciences or higher-level qualifications.
9. Extensive and proven experience in EU Regulatory Affairs (SME – Subject Matter Expert)
10. Must have 5+yrs experience of full lifecycle of existing or new product registrations including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.
11. In-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
12. Effective verbal and written communication skills.
13. Proven experience in managing large volume and fast paced product portfolios.
14. Flexible approach to enable prioritisation in line with company requirements.
15. Previous experience in mentoring junior team members of staff including SROs & ROs.
If this role is of interest to you, please apply now!
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