Principle Registration Officer
2 weeks ago
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 aReg 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 Officerto help maintain manufacturing operations. Responsibilities:- 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.
- Manage & coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, liaising directly with Agencies as Subject Matter Expert.
- Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
- 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.
- Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
- Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
- 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.
- BSc in Life sciences or higher-level qualifications.
- Extensive and proven experience in EU Regulatory Affairs (SME – Subject Matter Expert)
- 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.
- In-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
- Effective verbal and written communication skills.
- Proven experience in managing large volume and fast paced product portfolios.
- Flexible approach to enable prioritisation in line with company requirements.
- Previous experience in mentoring junior team members of staff including SROs & ROs.
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