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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 is essential; strong communication and project management skills are a plus.
- 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
Network with professionals in the regulatory affairs field, especially those who have experience with UK and Irish health authorities. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends in regulatory strategies.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines set by the MHRA, HPRA, and EMA. Understanding their processes will not only help you in interviews but also demonstrate your commitment to the role and the industry.
✨Tip Number 3
Prepare to discuss your experience with product marketing authorisations and lifecycle management during the interview. Be ready to share specific examples of how you've successfully navigated regulatory challenges in the past.
✨Tip Number 4
Showcase your mentoring skills by discussing any previous experiences where you've coached junior staff. Highlighting your ability to lead and support others can set you apart as a candidate who adds value to the team.
We think you need these skills to ace Senior Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly 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 understanding of the industry. Mention your experience with product Marketing Authorisations and how you can contribute to the company's goals.
Highlight Mentorship Experience: Since the role involves mentoring junior staff, be sure to include any relevant experience you have in coaching or leading teams. This will demonstrate your leadership skills and ability to support others in their professional development.
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 show your expertise and readiness for the role.
✨Demonstrate Project Management Skills
Prepare examples of how you've successfully managed regulatory projects in the past. Highlight your ability to coordinate submissions and follow up on applications, as this is crucial for the position.
✨Showcase Mentorship Experience
Since mentoring junior staff is part of the role, be ready to discuss any previous experience you have in coaching or training others. This will demonstrate your leadership capabilities.
✨Align with Company Goals
Research the company’s portfolio and recent product launches. Be prepared to discuss how your regulatory strategies can align with their business goals and contribute to their success.
