Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Join a global pharma team as a Regulatory Officer, ensuring product compliance and smooth launches.
- Company: Work with a leading pharmaceutical organisation in the heart of Dublin.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and mentorship.
- Why this job: Make an impact in life sciences while collaborating with experts in a supportive culture.
- Qualifications: BSc in Life Sciences and 5+ years in EU Regulatory Affairs required.
- Other info: Remote work options may be available; apply now to kickstart your career!
The predicted salary is between 43200 - 72000 £ per year.
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:
- 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.
- 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.
- Maintain databases and systems in accordance with current SOPs to fulfill regulatory obligations.
- 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.
- Stay informed about regulatory requirements, including legislation, guidelines, industry best practices, and liaise with competent authorities.
- Provide expertise and support to the department, including mentoring and training in specialist areas as required.
- Participate in Principal Registration Officer meetings, proactively raise issues, collaborate on solutions, and ensure dissemination of decisions to junior team members.
Requirements:
- BSc in Life Sciences or higher qualifications.
- Extensive proven experience in EU Regulatory Affairs as a Subject Matter Expert.
- 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.
- In-depth understanding of DCP / MRP processes, with examples of estimating approval times and handling variations and submissions.
- Effective verbal and written communication skills.
- Experience managing large, fast-paced product portfolios.
- Flexible approach to prioritize tasks according to company needs.
- 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. Bank or payment details should not be provided when applying. All applications should be made via the 'Apply now' button.
Principle Registration Officer employer: Quanta part of QCS Staffing
Contact Detail:
Quanta part of QCS Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principle Registration Officer
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry in both EU and non-EU territories. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals already working in regulatory affairs, especially those who have experience with DCP/MRP processes. Engaging in discussions or attending industry events can provide insights and potentially lead to referrals that could strengthen your application.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed product registrations or navigated complex regulatory challenges. Highlighting these instances will showcase your expertise and problem-solving skills to potential employers.
✨Tip Number 4
Stay informed about recent changes in regulations and industry best practices by following relevant publications and joining professional associations. This proactive approach will not only enhance your knowledge but also position you as a well-informed candidate during interviews.
We think you need these skills to ace Principle Registration Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in EU Regulatory Affairs, particularly your work with product registrations and the DCP/MRP processes. Use specific examples to demonstrate your expertise.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Mention your BSc in Life Sciences and how your extensive experience aligns with the responsibilities of the Principal Registration Officer position.
Showcase Communication Skills: Since effective verbal and written communication skills are crucial for this role, consider including examples in your application that demonstrate your ability to communicate complex regulatory information clearly and effectively.
Highlight Mentoring Experience: If you have experience mentoring junior staff, be sure to include this in your application. Discuss how you've supported and trained others in regulatory affairs, as this is a key aspect of the role.
How to prepare for a job interview at Quanta part of QCS Staffing
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in EU Regulatory Affairs. Be prepared to discuss specific examples of how you've managed the full lifecycle of product registrations, including strategy and planning.
✨Demonstrate Your Knowledge of DCP/MRP Processes
Familiarise yourself with the DCP and MRP processes, as well as any recent changes in regulations. Be ready to explain how you've estimated approval times and handled variations in past roles.
✨Communicate Effectively
Since effective verbal and written communication skills are crucial for this role, practice articulating your thoughts clearly. Prepare to discuss how you've advised senior management on project statuses and proposed solutions to potential problems.
✨Emphasise Mentoring Experience
Given the importance of mentoring junior staff in this position, be sure to share your experiences in training and supporting others. Highlight any specific instances where your guidance led to successful outcomes.
