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 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 authorisations for designated EU and non-EU territories to ensure on-time launches, continued supply, and product compliance.
2. Manage and coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, and liaising with agencies as a Subject Matter Expert.
3. Maintain databases and systems in accordance with SOPs to fulfill regulatory obligations.
4. Advise senior management on the status and progress of projects, identifying potential issues and proposing solutions.
5. Stay informed about regulatory requirements, including legislation, guidelines, and industry best practices, through liaison with authorities.
6. Provide expertise and support to the department, including mentoring and training in specialist areas.
7. Participate in Principal Registration Officer meetings, raising issues and collaborating on solutions, and disseminating decisions to junior team members.
Requirements:
1. BSc in Life Sciences or higher qualifications.
2. Extensive experience in EU Regulatory Affairs as a Subject Matter Expert.
3. At least 5 years of experience in the full lifecycle of product registrations, including strategy, planning, monitoring, post-marketing approvals, and launches in accordance with EU regulations.
4. Deep understanding of DCP / MRP processes, including estimating approval times and handling variations and submissions.
5. Effective verbal and written communication skills.
6. Proven ability to manage large, fast-paced product portfolios.
7. Flexible approach to prioritization based on company needs.
8. Previous experience mentoring junior staff, including SROs and ROs.
If this role interests you, please apply now!
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