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- Tasks: Lead regulatory strategy for medicinal products and vaccines, ensuring compliance with health authorities.
- Company: Join a dynamic Pharmaceutical Manufacturing organisation based in Reading, focused on innovative healthcare solutions.
- Benefits: Enjoy a hybrid work model with three office days per week and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while mentoring junior staff and working on diverse disease areas.
- Qualifications: Experience in Regulatory Affairs and knowledge of UK and Ireland regulations are essential.
- Other info: This is a long-term contract role with potential for career advancement.
The predicted salary is between 43200 - 72000 £ per year.
I am looking to speak with Senior Regulatory Affairs professionals looking for a long-term contract with a Pharmaceutical Manufacturing organisation based in Reading. The UK and Ireland Regulatory Affairs Department is responsible for leading the regulatory strategy for a large portfolio of medicinal products and vaccines.
In this role, our team engages with Health Authorities (MHRA, HPRA, EMA) to ensure the compliant pre-licensing application and post-licensing life-cycle management activities for the Marketing Authorisations held for these products for the UK and Ireland. The portfolio covers a wide range of disease areas including neurological diseases, diabetes, respiratory, cardiovascular, oncology and rare diseases.
Job Purpose: To obtain, manage and maintain product Marketing Authorisations in line with business goals and legal requirements. To conduct associated regulatory activities for the specified markets with minimal supervision, and to contribute to the implementation and leading of projects. To mentor/coach junior members of staff, supporting regulatory, product and or therapeutic area knowledge.
Main Responsibilities:
- Co-ordinates, prepares, submits and follows up registration applications to the UK and/or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
- Supports the launch of new products and life cycle management of the existing portfolio.
- Assist and provide support in the preparation, distribution and follow up of registration documentation required in the EU (particularly UK and Ireland).
Hybrid - 3 office days a week (office days would need to align with team days, with one being a Monday or a Friday). If interested please apply with your updated CV and we can discuss in more detail.
Senior Regulatory Affairs Specialist employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks of the UK and Ireland, particularly the MHRA and HPRA guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the local regulatory landscape.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with pharmaceutical manufacturing. Attend industry events or webinars to connect with potential colleagues and learn about current trends and challenges in the sector.
✨Tip Number 3
Prepare to discuss your experience with product marketing authorisations and lifecycle management during interviews. Be ready to share specific examples of how you've successfully navigated regulatory processes in the past.
✨Tip Number 4
Showcase your mentoring skills by highlighting any experience you have in coaching junior staff. This is a key aspect of the role, so be prepared to discuss how you've supported others in their professional development.
We think you need these skills to ace Senior Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of a Senior Regulatory Affairs Specialist. Familiarise yourself with the regulatory landscape in the UK and Ireland, especially regarding medicinal products and vaccines.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly in the pharmaceutical sector. Emphasise your familiarity with Health Authorities like MHRA, HPRA, and EMA, and any specific projects you've led or contributed to.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your ability to manage product Marketing Authorisations. Mention your experience in mentoring junior staff and how you can contribute to the team’s success.
Highlight Relevant Skills: In your application, be sure to highlight key skills such as project management, attention to detail, and your ability to work independently. These are crucial for the role and will help you stand out to the hiring team.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Familiarise yourself with the specific regulations and guidelines set by the MHRA, HPRA, and EMA. Being able to discuss these in detail will demonstrate your expertise and show that you are well-prepared for the role.
✨Showcase Your Experience
Prepare examples from your past work where you successfully managed marketing authorisations or navigated regulatory challenges. Highlighting your achievements will help you stand out as a candidate who can contribute effectively to the team.
✨Emphasise Team Collaboration
Since this role involves mentoring junior staff and working closely with a team, be ready to discuss your experience in collaboration and leadership. Share instances where you have supported others or led projects to success.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and future projects. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
