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- Tasks: Manage product life cycles and regulatory submissions for the UK and EU.
- Company: Join a leading Pharmaceutical company in the Kent area.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring compliance and safety of products.
- Qualifications: Degree in science or equivalent experience; proven Regulatory Affairs background required.
- Other info: Strong communication and project management skills are essential.
The predicted salary is between 43200 - 72000 £ per year.
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Role Overview
We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications.
Your expertise will be instrumental in writing, compiling, and publishing dossiers for UK National & EU submissions, ensuring compliance with regulatory requirements.
Key Duties and Responsibilities
Your duties as the Regulatory Affairs Manager will be varied; however, the key duties and responsibilities are as follows:
- Oversee dossier compilation and submission for UK and EU markets.
- Liaise with regulatory bodies and manage communication regarding variations.
- Develop product information and approve artwork for regulatory compliance.
- Ensure that CMC practices align with regulatory standards, developing clear justifications for new product licenses and variations.
Role Requirements
To be successful in your application for this exciting role as the Regulatory Affairs Manager, we are looking to identify the following on your profile and past experience:
- Educated to degree level in science or equivalent experience.
- Proven experience in Regulatory Affairs within the Pharmaceutical industry.
- Strong communication and project management skills.
- Proficiency in MS Office suite and regulatory submission portals.
Key Words: Regulatory Affairs Officer | Pharmaceutical | Life Cycle Management | CMC | Clinical | Safety | Product Information | Dossier | Submission | Variations | MA Transfer | eCTD | EMC | MHRA | CESP | Artwork | Pharmacovigilance
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Senior Regulatory Affairs Officer employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Officer
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for the UK and EU markets. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, especially those who have experience in the pharmaceutical industry. Engaging with them can provide insights into the company culture and expectations, which can be beneficial during the application process.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs by following relevant publications and attending webinars. This knowledge can set you apart from other candidates and show your proactive approach to professional development.
✨Tip Number 4
Prepare to discuss specific examples from your past experience that highlight your skills in dossier compilation and communication with regulatory bodies. Being able to articulate these experiences clearly will strengthen your candidacy.
We think you need these skills to ace Senior Regulatory Affairs Officer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Affairs Officer position. Understand the key responsibilities and requirements, especially focusing on CMC, clinical, safety, and product information modifications.
Highlight Relevant Experience: In your CV and cover letter, emphasize your proven experience in Regulatory Affairs within the Pharmaceutical industry. Provide specific examples of your work with dossier compilation and submission for UK and EU markets.
Showcase Communication Skills: Since strong communication skills are essential for this role, include examples of how you've effectively liaised with regulatory bodies or managed project communications in your previous positions.
Tailor Your Application: Customize your application materials to reflect the specific requirements mentioned in the job description. Use keywords related to regulatory compliance, CMC practices, and project management to align your application with the company's needs.
How to prepare for a job interview at TN United Kingdom
✨Showcase Your Regulatory Knowledge
Be prepared to discuss your experience with regulatory submissions, particularly in the UK and EU markets. Highlight specific examples of dossiers you've compiled and any interactions you've had with regulatory bodies.
✨Demonstrate Strong Communication Skills
Since the role requires liaising with regulatory bodies, practice articulating complex regulatory concepts clearly and concisely. Use examples from your past experiences to illustrate how you effectively communicated with stakeholders.
✨Highlight Project Management Experience
Discuss your project management skills and how you've successfully managed timelines and deliverables in previous roles. Be ready to provide examples of how you prioritized tasks and ensured compliance with regulatory standards.
✨Familiarize Yourself with CMC Practices
Understand the Chemistry, Manufacturing, and Controls (CMC) aspects relevant to the role. Be prepared to discuss how you have developed justifications for new product licenses and variations, showcasing your expertise in this area.
