Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory strategies and submissions for FDA and MHRA in a dynamic environment.
- Company: Join a growing pharmaceutical/medical device company in Deeside, specialising in innovative challenge meals.
- Benefits: Enjoy 25 holidays, private healthcare, and discounts at high street stores.
- Why this job: Be part of a team that shapes the future of healthcare with impactful projects and a supportive culture.
- Qualifications: Bachelor's degree in a scientific field and 5+ years in regulatory affairs required.
- Other info: Mid-senior level role with opportunities for career development and project management.
The predicted salary is between 36000 - 60000 £ per year.
5 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
About
Regulatory Affairs Manager
I am working with a pharmaceutical/ Medical Device manufacturing site based in Deeside specialising in challenge meals, this is a good opportunity for a experienced Regulatory Affairs Manager to develop their career with an expanding company.
Key responsibilities for the Regulatory Affairs Manager
Develop and implement regulatory strategies for FDA and MHRA submissions. Lead the preparation, submission, and lifecycle management of regulatory dossiers. Work closely with the director with FDA and MHRA, coordinating meetings, and inspection readiness. Monitor changes in global regulatory landscapes and assess impact on ongoing and future projects. Provide regulatory guidance during product development, labelling, and promotional review processes.
Requirements for the Regulatory Affairs Manager
Bachelor\’s degree in a scientific discipline or a related subject. Minimum 5 years\’ experience in regulatory affairs, with demonstrable expertise in both FDA and MHRA regulatory processes. Strong knowledge of global regulatory standards Proven success in authoring and managing regulatory submissions and renewals. Excellent communication, leadership, and project management skills.
Benefits for the Regulatory Affairs Manager
25 holidays per year + Bank Holidays Christmas shutdown. Cycle to work scheme Private healthcare High street discount scheme
To apply for the Regulatory Affairs Manager or here more information, please contact Liam Shannon at Smart4Sciences on (phone number removed) or email me at
Nice-to-have skills
- Project Management
- Deeside, Wales
Languages
- English
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Legal
-
Industries
Technology, Information and Internet
Referrals increase your chances of interviewing at TieTalent by 2x
Cheshire West And Chester, England, United Kingdom 2 weeks ago
Chester, England, United Kingdom 5 days ago
Winsford, England, United Kingdom 2 weeks ago
Regulatory Transaction Reporting Project Manager
Chester, England, United Kingdom 2 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Regulatory Affairs Manager employer: TieTalent
Contact Detail:
TieTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest FDA and MHRA regulations. Staying updated on any changes in these regulatory frameworks will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with FDA and MHRA submissions. Engaging in discussions or attending relevant conferences can provide valuable insights and connections that may help you stand out.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing regulatory submissions. Highlighting your successes and challenges faced in previous roles will showcase your expertise and problem-solving skills to potential employers.
✨Tip Number 4
Research the company’s products and their regulatory history. Understanding their portfolio and any recent developments will allow you to tailor your conversation and show genuine interest in how you can contribute to their success.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, particularly with FDA and MHRA processes. Use specific examples of your past work that align with the responsibilities listed in the job description.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your understanding of the pharmaceutical and medical device industries. Mention your ability to develop regulatory strategies and your experience with lifecycle management of regulatory dossiers.
Highlight Relevant Skills: In your application, emphasise your project management skills and any leadership experience you have. These are crucial for the role and should be clearly articulated in both your CV and cover letter.
Proofread Your Application: Before submitting, carefully proofread your application materials. Look for any spelling or grammatical errors, and ensure that all information is accurate and presented professionally.
How to prepare for a job interview at TieTalent
✨Know Your Regulations
Make sure you have a solid understanding of both FDA and MHRA regulations. Brush up on recent changes in the regulatory landscape, as this will show your commitment to staying informed and your ability to adapt strategies accordingly.
✨Demonstrate Leadership Skills
As a Regulatory Affairs Manager, you'll need to lead teams and coordinate with various departments. Prepare examples from your past experiences where you've successfully led projects or guided teams through complex regulatory processes.
✨Prepare for Technical Questions
Expect technical questions related to regulatory submissions and lifecycle management. Be ready to discuss specific dossiers you've worked on, the challenges faced, and how you overcame them. This will highlight your expertise and problem-solving skills.
✨Showcase Communication Skills
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely. You might be asked to explain complex regulatory concepts, so being able to simplify these for different audiences will be crucial.
