Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory processes for marketing authorizations in the UK and Ireland.
- Company: Join a dynamic medium/large-sized pharmaceutical company making an impact.
- Benefits: Enjoy a competitive salary, hybrid work options, and a comprehensive benefits package.
- Why this job: Be at the forefront of regulatory affairs, shaping strategies and mentoring a talented team.
- Qualifications: 6+ years of UK regulatory experience and a relevant scientific degree required.
- Other info: This role is based in West London with a hybrid working model.
The predicted salary is between 43200 - 72000 £ per year.
Social network you want to login/join with:
Regulatory Affairs Lead UK/IRE, Greater London
Client: Cpl
Location: Greater London, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference:
Job Views:
7
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Job Title: Regulatory Affairs Lead– UK affiliates
Location: West London, UK (Hybrid)
Remuneration: Attractive salary and package
Role Type: Full Time, permanent position
An exciting opportunity to join a medium/large-sized pharmaceutical company and work as a UK and Ireland Lead. This is a great opportunity to demonstrate your knowledge in managing regulatory processes for gaining marketing authorisation and CTA to the maintenance of licenses in the UK and Ireland markets.
You will be accountable for leading the UK/IRE Regulatory Affairs team and providing regulatory leadership, guidance, and strategy for assigned marketed products and development projects in Ireland and the UK. This includes support and execution of regulatory activities.
Responsibilities:
- Act as the regulatory liaison and primary contact person for MHRA and HPRA, support or lead negotiations on regulatory issues with both agencies, organize meetings and teleconferences if required.
- Drive all UK affiliate related activities including Regulatory Affairs Strategies, leading pre submission meetings, health authority interactions, and other pre-approval activities.
- Lead and manage timely submissions of CTA and MAA for the UK and Ireland.
- In close collaboration with the Global and European Regulatory Team, develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders.
- Advise on national submissions and evaluate the content and adequacy of regulatory submissions, identifying deficiencies requiring further resolution.
- Provide and prepare national information and documents for submission including documents required for labelling.
- Lead the UK RA team and provide regulatory guidance and strategy. Mentor and develop RA staff in the UK RA team.
- Ensure timely delivery of national regulatory submissions, track and report national deadlines and submissions.
- Maintain licenses of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the headquarters informed about the status of submissions and implementation of changes.
Experience required:
- Bachelors or advanced degree in an appropriate scientific discipline
- Experienced (approx. 6+ years) UK regulatory professional having managed major submissions and approvals via MHRA regulatory pathways
- Experience handling UK applications post-Brexit
- Knowledge of clinical trial requirements and procedures
- Ability to think strategically, sound commercial awareness, and good knowledge of medicines development within EU
The role will require the right candidate to be based in the UK and be willing to commute to West London on a Hybrid basis. The position has an excellent benefits package on offer.
For more details please reach out to or call.
#J-18808-Ljbffr
Regulatory Affairs Lead UK/IRE employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Lead UK/IRE
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines from the MHRA and HPRA. Understanding their processes and requirements will help you stand out as a knowledgeable candidate who can effectively lead regulatory affairs.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with UK and Ireland markets. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare for potential interviews by practicing how you would handle specific regulatory scenarios, such as negotiations with the MHRA or HPRA. Demonstrating your strategic thinking and problem-solving skills will be crucial.
✨Tip Number 4
Stay updated on post-Brexit regulatory changes that affect the UK and Ireland. Showing that you are proactive about understanding these shifts will highlight your commitment and expertise in the field.
We think you need these skills to ace Regulatory Affairs Lead UK/IRE
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Lead position. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in UK regulatory affairs, particularly with MHRA and post-Brexit applications. Use specific examples to demonstrate your expertise in managing submissions and approvals.
Showcase Leadership Skills: Since the role involves leading a team, be sure to highlight any previous leadership or mentoring experience. Discuss how you've successfully guided teams in regulatory processes or strategic planning.
Tailor Your Cover Letter: Craft a personalized cover letter that addresses the specific needs of the company. Mention your understanding of the UK and Ireland markets and how your skills align with their regulatory strategies.
How to prepare for a job interview at TN United Kingdom
✨Show Your Regulatory Expertise
Make sure to highlight your experience with UK regulatory processes, especially your familiarity with MHRA and HPRA. Be prepared to discuss specific examples of major submissions you've managed and how you navigated any challenges.
✨Demonstrate Strategic Thinking
Since the role requires strategic oversight, come prepared to discuss how you've developed and implemented regulatory strategies in the past. Think about how you can align your experiences with the company's goals and the specific needs of the UK and Ireland markets.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Practice articulating your thought process and decision-making when faced with regulatory challenges or tight deadlines.
✨Emphasize Team Leadership Skills
As you'll be leading a team, be ready to share your leadership philosophy and experiences. Discuss how you've mentored staff in the past and how you plan to foster a collaborative environment within the UK RA team.
