At a Glance
- Tasks: Author and review regulatory documents for post-approval variations in the pharmaceutical industry.
- Company: Join Apsida Life Science, a leader in life sciences recruitment with a global presence.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with a focus on collaboration and regulatory compliance.
- Why this job: Make a real impact in drug development while working with top industry experts.
- Qualifications: 4+ years in CMC Regulatory Affairs and strong Module 3 documentation skills.
The predicted salary is between 50000 - 65000 £ per year.
Apsida Life Science is partnering with a leading global clinical research organisation within the pharmaceutical and life sciences industry. The organisation has a strong international presence and provides comprehensive support across the drug development lifecycle, including clinical research, regulatory affairs, and post-approval activities.
Key Responsibilities
- Author, edit, and review Module 3 sections for UK post-approval variations.
- Update and maintain CTD sections in line with regulatory requirements.
- Review and approve Module 1 documents prepared for MHRA submissions.
- Support post-approval variation activities and related regulatory lifecycle submissions.
- Communicate with SMEs to obtain additional data, reports, and clarifications required for submissions.
- Create submission build lists and coordinate closely with submission managers.
- Review and assess change controls to ensure regulatory compliance and alignment.
- Support end-to-end coordination of documentation for regulatory submissions.
Requirements
- 4+ years experience in CMC Regulatory Affairs within the UK or EU environment.
- Strong hands-on experience with Module 3 authoring and CTD documentation.
- Experience supporting post-approval variations and regulatory lifecycle activities.
- Familiarity with MHRA regulatory requirements and expectations.
- Ability to coordinate effectively with SMEs, regulatory teams, and submission managers.
- Strong attention to detail and ability to manage multiple documentation streams.
- Previous experience in pharmaceutical or biopharmaceutical regulatory environments preferred.
Regulatory Affairs Specialist employer: Apsida Life Science
Apsida Life Science is an exceptional employer, offering a dynamic work culture that prioritises employee growth and development within the pharmaceutical and life sciences sector. With a strong international presence and a commitment to supporting the drug development lifecycle, employees benefit from flexible remote working arrangements, comprehensive training opportunities, and a collaborative environment that fosters innovation and excellence in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Module 3 authoring and CTD documentation. We recommend practising common interview questions related to post-approval variations and regulatory lifecycle activities.
✨Tip Number 3
Showcase your attention to detail! During interviews, share examples of how you’ve managed multiple documentation streams effectively. We want to see how you handle the nitty-gritty of regulatory compliance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way in your job search journey.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with Module 3 authoring and CTD documentation, as well as any familiarity with MHRA requirements. We want to see how your skills match what we're looking for!
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 background makes you a great fit for our team. Don’t forget to mention your experience with post-approval variations and regulatory lifecycle activities.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. When writing your application, make sure there are no typos or errors. We appreciate candidates who take the time to ensure their documents are polished and professional.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Apsida Life Science
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of Module 3 authoring and CTD documentation. Familiarise yourself with the latest MHRA requirements, as this will show that you're not just a candidate but someone who is genuinely interested in the role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed post-approval variations or coordinated with SMEs. This will help demonstrate your hands-on experience and how it aligns with what the company is looking for.
✨Be Ready to Discuss Compliance
Expect questions about regulatory compliance and change controls. Have a few scenarios ready where you ensured compliance in your previous roles, as this will highlight your attention to detail and ability to manage multiple documentation streams.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about the company's approach to regulatory submissions or their team dynamics. This shows your enthusiasm for the role and helps you gauge if it's the right fit for you.
