Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage marketing authorisations and ensure compliance for pharmaceutical products across EU and non-EU territories.
- Company: Join a global pharmaceutical organisation in the heart of Dublin.
- Benefits: Competitive salary, career development, and the chance to work in a dynamic environment.
- Why this job: Make a real impact in the life sciences sector while working with a passionate team.
- Qualifications: BSc in Life Sciences and 5+ years in EU Regulatory Affairs required.
- Other info: Opportunity to mentor junior staff and grow your career in a fast-paced industry.
The predicted salary is between 36000 - 60000 £ per year.
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 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 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 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+ years 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.
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
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulations and the DCP/MRP processes. We want you to be the go-to expert in the room, so practice articulating your experience with product registrations and compliance.
✨Tip Number 3
Showcase your mentoring skills! Be ready to discuss how you've trained junior team members in the past. Highlighting your leadership abilities can set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Principle Registration Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Registration Officer role. Highlight your experience in EU Regulatory Affairs and any specific achievements that align with the job description. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team. Be sure to mention your experience with product registrations and your understanding of regulatory requirements.
Showcase Your Communication Skills: Since effective communication is key in this role, make sure your written application reflects your ability to convey complex information clearly. We love candidates who can articulate their thoughts well, so don’t hold back on showcasing your writing prowess!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Quanta part of QCS Staffing
✨Know Your Stuff
Make sure you brush up on your knowledge of EU Regulatory Affairs, especially around DCP and MRP processes. Be ready to discuss specific examples from your past experience that demonstrate your expertise in managing product registrations and compliance.
✨Showcase Your Problem-Solving Skills
Prepare to talk about challenges you've faced in previous roles, particularly regarding delays or compliance issues. Highlight how you identified these problems and the solutions you implemented to keep things on track.
✨Communicate Clearly
Since effective communication is key for this role, practice articulating your thoughts clearly and concisely. You might be asked to explain complex regulatory concepts, so being able to simplify them will show your mastery of the subject.
✨Mentorship Matters
Be ready to discuss your experience in mentoring junior team members. Share specific instances where you provided guidance or training, and how that contributed to the team's success. This will demonstrate your leadership skills and commitment to team development.
