At a Glance
- Tasks: Manage regulatory submissions and liaise with health authorities for timely approvals.
- Company: Rapidly growing Regulatory Affairs consultancy with major pharmaceutical clients.
- Benefits: Part-time remote work, flexible hours, and outside IR35 contract.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Strong UK and Ireland regulatory background with post-Brexit experience.
- Other info: Opportunity for career growth in a fast-paced environment.
The predicted salary is between 30000 - 40000 £ per year.
This is a rapidly growing Regulatory Affairs consultancy that is looking for an experienced Regulatory Affairs Manager who specialises in UK and Ireland registrations to fulfil a 12-month, remote contract which is outside IR35. They count some of the biggest multinational pharmaceutical companies as clients and continue to provide regulatory solutions that drive success.
Your new role
- Regulatory Submissions & Health Authority Interactions: prepare and submit regulatory applications to the MHRA (UK) and HPRA (Ireland), including variations, renewals, and notifications, manage post-submission queries and liaise directly with Health Authorities to ensure timely approvals and monitor and interpret local regulatory changes and communicate impact to internal stakeholders.
- Labelling & Product Information Management: Lead updates to local labelling, including SmPCs, PILs, and packaging texts, ensuring alignment with EU and local requirements. Coordinate translations and ensure accuracy and compliance with approved English reference texts and collaborate with internal teams to implement labelling changes in a timely manner.
What you'll need to succeed
This is a fast-paced, busy team, and we are looking for someone with a strong UK and Ire Regulatory background who can hit the ground running. It is essential that those applying for this job have post-Brexit, International Recognition Procedure (IRP) experience.
What you'll get in return
This is a part-time contract job, 20 hours per week. It is fully remote and outside IR35.
What you need to do now
For more information on this Regulatory Affairs Manager UK and Ireland job, please apply. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Regulatory Affairs Consultant Uk and Ire outside IR35 in Slough employer: Hays Life Sciences
Contact Detail:
Hays Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant Uk and Ire outside IR35 in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with UK and Ireland registrations. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of post-Brexit regulations and the International Recognition Procedure (IRP). We want you to be ready to impress with your expertise and show that you can hit the ground running!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for roles that suit your skills, like the Regulatory Affairs Manager position, and tailor your approach to each opportunity.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Regulatory Affairs Consultant Uk and Ire outside IR35 in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in UK and Ireland regulatory affairs. We want to see how your background aligns with the specific requirements of the role, especially your post-Brexit experience.
Showcase Relevant Skills: In your application, emphasise skills that are crucial for this role, like managing regulatory submissions and liaising with health authorities. We’re looking for someone who can hit the ground running, so make those skills pop!
Keep It Concise: While we love detail, keep your application concise and to the point. Highlight your most relevant experiences and achievements without overwhelming us with too much information.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulations
Make sure you brush up on the latest UK and Ireland regulatory requirements, especially post-Brexit changes. Being able to discuss these confidently will show that you're not just familiar with the basics but are also up-to-date with current practices.
✨Prepare for Health Authority Interactions
Think about potential questions related to your experience with MHRA and HPRA submissions. Be ready to share specific examples of how you've managed post-submission queries or liaised with health authorities in the past.
✨Showcase Your Labelling Expertise
Since labelling is a key part of the role, prepare to discuss your experience with SmPCs, PILs, and packaging texts. Highlight any projects where you led updates or ensured compliance with local and EU requirements.
✨Demonstrate Your Team Collaboration Skills
This role involves working closely with internal teams. Be prepared to talk about how you've successfully collaborated with others in previous roles, particularly when implementing labelling changes or managing translations.