Principle Registration Officer
- London
- Permanent
- CAPEX Projects
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:
- 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.
Requirements:
- 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.
If this role is of interest to you, please apply now!
#LI-KT1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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