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- Tasks: Manage regulatory affairs for UK, Ireland, and Malta; ensure timely submissions and approvals.
- Company: Join Planet Pharma, a top-rated global staffing agency recognized by FORBES.
- Benefits: Enjoy a hybrid work schedule with competitive salary and growth opportunities.
- Why this job: Be part of a dynamic team during an exciting growth phase in the pharmaceutical industry.
- Qualifications: 6-12 months of regulatory experience, especially with MHRA submissions, is essential.
- Other info: We value diversity and welcome applications from all qualified candidates.
The predicted salary is between 28800 - 42000 £ per year.
Role: Regulatory Affairs Officer
Location: Uxbridge, UK – Hybrid working schedule (2 days WFH)
Salary: Very competitive salary on offer
Our client is a large global pharmaceutical company and they are seeking a Regulatory Affairs Officer to join them during an exciting period of growth! This candidate must have 6-12 months regulatory experience and will have the opportunity to broaden their knowledge and experience.
Role summary:
Manage the operational and technical aspects of regulatory affairs for the UK, Ireland and Maltese marketing affiliates.
Responsibilities:
- Implement Regulatory Plan in-line with affiliate business plans
- Ensure Submissions and Approvals for Regulatory Applications in a timely manor.
- Prepare and support new MAAs
- Assist with the maintenance for MAAs
Requirements:
- 6-12+ months experience in Regulatory Affairs
- Experience with submissions to the MHRA is essential
- Experience with RIMS and TRACKWISE
- Experience with UK
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
Regulatory Affairs Officer employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for the UK, Ireland, and Malta. Understanding the nuances of each market will help you stand out as a candidate who is ready to hit the ground running.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with MHRA submissions. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs by following relevant publications and attending webinars. This knowledge will not only enhance your expertise but also demonstrate your commitment to the field.
✨Tip Number 4
Prepare to discuss your experience with RIMS and TRACKWISE during interviews. Being able to articulate how you've used these systems in past roles will show that you're well-equipped for the responsibilities of the position.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Officer position. Highlight key responsibilities and requirements, such as experience with MHRA submissions and knowledge of RIMS and TRACKWISE.
Tailor Your CV: Customize your CV to emphasize your relevant regulatory experience, particularly any roles or projects that involved submissions to the MHRA. Use specific examples to demonstrate your skills and achievements in regulatory affairs.
Craft a Compelling Cover Letter: Write a cover letter that connects your experience directly to the job requirements. Mention your familiarity with the UK regulatory environment and express your enthusiasm for joining a global pharmaceutical company during its growth phase.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Planet Pharma
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the regulatory environment in the UK, Ireland, and Malta. Familiarize yourself with the MHRA submission process and any recent changes in regulations that may impact your role.
✨Highlight Relevant Experience
Prepare to discuss your previous experience in regulatory affairs, especially any specific projects or submissions you've worked on. Be ready to explain how your background aligns with the requirements of the position.
✨Demonstrate Technical Skills
Since experience with RIMS and TRACKWISE is essential, be prepared to discuss your proficiency with these systems. If possible, provide examples of how you've used them in past roles to manage regulatory submissions.
✨Show Enthusiasm for Growth
This company is in an exciting period of growth, so express your enthusiasm for being part of that journey. Discuss how you can contribute to their success and your eagerness to learn and expand your knowledge in regulatory affairs.
