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- Tasks: Join a dynamic team to manage regulatory compliance and guide projects in the pharmaceutical industry.
- Company: A growing pharmaceutical company focused on innovation and compliance.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Other info: Fully office-based role with no hybrid working options.
- Why this job: Make a real impact in healthcare by ensuring regulatory standards are met.
- Qualifications: Pharmacy/Chemistry degree and 2+ years in Regulatory Affairs required.
The predicted salary is between 35000 - 45000 £ per year.
An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Regulatory team. With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance as well as the opportunity to supervise and guide a team.
Please note that this role is fully office based (5 days per week) and hybrid working is not available.
Responsibilities:- Converting an existing application to eCTD format.
- Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
- Ensure completion of post-approval commitments, if any.
- Compilation and maintaining Product license files.
- Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
- Process and communicate regulatory approvals internally and to external stakeholders.
- Participate in the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information, and batch recall to determine the need for any regulatory activities and to ensure compliance with regulatory requirements.
- Maintain regulatory files/database and chronologies in good order.
- Maintain system for tracking changes in documents submitted to agencies or partners.
- Publishing activities including converting/binding of pdf files, resolve validation issues.
- Compile and submit variations.
- Working in accordance with Company’s working Instructions and SOPs.
- Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.
- Pharmacy/Chemistry degree.
- 2+ years Regulatory Affairs experience.
- Understanding of the current UK and European regulations, laws, guidelines, and industry requirements.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
- Experience with Generic products and MRP/DCP submissions is advantageous.
Regulatory Affairs Officer employer: Select Pharma Recruitment
Contact Detail:
Select Pharma Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in Regulatory Affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and European regulations. Be ready to discuss how your experience aligns with the responsibilities listed in the job description, especially around post-approval activities.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your previous work in Regulatory Affairs, particularly any experience with eCTD formats or MA submissions. This will give you an edge during interviews.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you a better chance of landing that interview.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs role. Highlight your relevant experience, especially in post-approval activities and eCTD format. We want to see how your background aligns 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 Regulatory Affairs and how your skills can contribute to our growing team. Keep it engaging and personal – we love a bit of personality!
Showcase Your Knowledge: Demonstrate your understanding of UK and European regulations in your application. Mention any specific experiences you've had with compliance or regulatory submissions. This shows us you’re not just a fit on paper but also in practice!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it makes the process smoother for both of us!
How to prepare for a job interview at Select Pharma Recruitment
✨Know Your Regulations
Make sure you brush up on the current UK and European regulations, laws, and guidelines relevant to Regulatory Affairs. Being able to discuss these confidently will show your potential employer that you're not just familiar with the basics but are genuinely engaged with the field.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in post-approval activities and eCTD submissions. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easier for the interviewer to see your impact.
✨Team Player Mindset
Since this role involves supervising and guiding a team, be ready to discuss your leadership style and how you’ve successfully collaborated with others in previous positions. Share instances where you coordinated regulatory activities or managed cross-functional teams.
✨Stay Organised
Demonstrate your organisational skills by discussing how you maintain regulatory files and track changes in documents. You might even want to bring a sample of your work (if appropriate) to showcase your attention to detail and commitment to compliance.