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- Tasks: Manage regulatory compliance and post-approval activities in a dynamic pharmaceutical environment.
- Company: Growing generic pharmaceutical company with a focus on innovation.
- Benefits: Competitive salary, professional development, and a collaborative work culture.
- Why this job: Join a team making a real impact in the pharmaceutical industry.
- Qualifications: Pharmacy/Chemistry degree and 7-10 years of Regulatory Affairs experience required.
- Other info: Onsite role with opportunities for career advancement.
The predicted salary is between 36000 - 60000 £ per year.
An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.
Responsibilities:
- Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team.
- Have an excellent understanding of and be able to execute activities related to the following key areas:
- Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions.
- Reclassification of Medicines.
- Re-baseline / Remediation dossiers.
- License Transfers (giving away and bringing in) including the due diligence of dossiers.
- Maintenance of Marketing Authorisations including renewals.
- Deficiency responses to authorities.
- Interfacing with regulatory authorities to facilitate the approval of submissions.
- Work with sites (manufacturing, PV service provider)/appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
- Act as the primary contact point for Regulatory Affairs with the business units, customers, and other internal/external teams.
- Stay informed about new and changing regulatory requirements and ensuring compliance.
- Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
- Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
- Maintain up-to-date records and documentation in relation to Marketing Authorisations.
- Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
- Support other regulatory staff members within the Company when necessary.
- Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
- Any other task given to you by relevant stakeholder in order for you to be able to perform your role.
Required Skills:
- Pharmacy/Chemistry degree.
- 7-10 years Regulatory Affairs experience.
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
- Experience with Generic products and MRP/DCP submissions is advantageous.
- Clear understanding and ability to manage:
- National Procedure (MHRA).
- MRP, DCP – Preferable.
- Any other regulatory body submissions – Added advantage.
- MHRA Portal.
- Eudralink.
- CESP.
Regulatory Affairs Manager in Slough employer: Select Pharma Recruitment
Contact Detail:
Select Pharma Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and European regulations. Be ready to discuss how your experience aligns with the responsibilities listed in the job description, especially around compliance and post-approval activities.
✨Tip Number 3
Showcase your expertise! Bring examples of your past work, particularly any successful submissions or interactions with regulatory authorities. This will demonstrate your hands-on experience and problem-solving skills.
✨Tip Number 4
Don’t forget to apply through our website! We’re always looking for talented individuals like you, and applying directly can sometimes give you an edge over other candidates.
We think you need these skills to ace Regulatory Affairs Manager in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience, especially in post-approval activities and compliance. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can benefit us. Be specific about your experience with variations and license transfers.
Showcase Your Knowledge: Demonstrate your understanding of UK and European regulations in your application. Mention any specific experiences you've had with MRP/DCP submissions or working with regulatory authorities. We love candidates who are up-to-date with industry standards!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Select Pharma Recruitment
✨Know Your Regulations
Make sure you brush up on the current UK and European regulations, laws, and guidelines relevant to the role. Being able to discuss specific regulations and how they apply to the company's operations will show that you're not just familiar with the basics but are genuinely engaged with the field.
✨Showcase Your Experience
Prepare to discuss your 7-10 years of Regulatory Affairs experience in detail. Highlight specific projects you've worked on, especially those involving variations, license transfers, or compliance activities. Use examples that demonstrate your problem-solving skills and ability to interface with regulatory authorities.
✨Understand the Company’s Portfolio
Familiarise yourself with the company’s portfolio of generic products and any recent news or changes in their regulatory landscape. This knowledge will help you tailor your answers and show that you’re genuinely interested in contributing to their success.
✨Prepare Questions
Have a few thoughtful questions ready to ask at the end of the interview. This could be about their approach to regulatory challenges or how they support their Regulatory Affairs team. It shows that you’re proactive and keen to understand how you can fit into their culture and processes.
