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- Tasks: Create clear and accurate regulatory documents for clients and authorities.
- Company: Join a dynamic team focused on high-quality regulatory writing in the healthcare sector.
- Benefits: Enjoy unlimited holiday, flexible hours, bonuses, and comprehensive training.
- Why this job: Be part of a meaningful role that impacts healthcare while working remotely.
- Qualifications: No specific experience required; just a passion for detail and communication.
- Other info: Work on diverse projects across various therapeutic areas.
The predicted salary is between 36000 - 60000 £ per year.
PRIMARY PURPOSE OF THE ROLE
To provide high-quality, concise, and accurate regulatory documentation that meets the expectations of both clients and regulatory authorities.
CORE RESPONSIBILITIES
- Author regulatory documents across various therapeutic areas, ensuring outputs are clear, factual, scientifically accurate, and free from over-interpretation.
- Adhere to established standard operating procedures and regulatory processes provided by clients.
- Demonstrate a foundational understanding of the expectations of regulatory authorities for submissions.
- Review client-supplied materials critically, including protocols, statistical analysis plans (SAPs), data listings, templates, and style guidelines.
- Assess documentation quality, data integrity, and project resource use—taking prompt action where issues are identified.
- Conduct accurate data checks of documents created by peers to ensure consistency and quality.
- Perform literature searches using publicly available or commercial databases to verify citations, locate references, and gather background context or regulatory precedent.
- Collaborate directly with clients to manage timelines and address emerging issues.
- Juggle multiple concurrent projects efficiently while meeting deadlines and maintaining quality standards.
- Proactively notify team members of risks or potential problems.
- Communicate clearly and professionally with internal team members and external contacts.
- Deliver work on time and within agreed-upon budgets.
- Follow internal and client-aligned procedures consistently.
- Contribute to additional duties as reasonably required to support project or business needs.
CORE DELIVERABLES
Produce a wide range of documents, which may include (but are not limited to):
- Clinical study protocols
- Clinical study reports (CSRs)
- Executive summaries
- Common Technical Document (CTD) clinical summaries
- Investigator brochures (IBs)
- Clinical trial authorisation (CTA) documents
- Patient narratives
BENEFITS
- Unlimited Holiday Policy (including office closure between Christmas and New Years)
- Bonus scheme
- Healthcare
- Pension
- Flexible working hours
- Extensive training development
Regulatory Writer employer: Meet Life Sciences
Contact Detail:
Meet Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Writer
✨Tip Number 1
Familiarise yourself with the specific regulatory guidelines relevant to the therapeutic areas you’ll be working in. Understanding these regulations will not only help you in your role but also demonstrate your commitment and expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory writing field. Attend webinars, join relevant LinkedIn groups, or participate in industry forums to connect with others who can provide insights and potentially refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss your experience with various types of regulatory documents during interviews. Be ready to share specific examples of how you've ensured clarity and accuracy in your previous work, as this will highlight your suitability for the role.
✨Tip Number 4
Stay updated on the latest trends and changes in regulatory requirements. This knowledge will not only enhance your skills but also show potential employers that you are proactive and dedicated to continuous learning in the field.
We think you need these skills to ace Regulatory Writer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Regulatory Writer. Familiarise yourself with the types of documents you will be expected to produce and the regulatory standards that must be adhered to.
Tailor Your CV: Highlight relevant experience in regulatory writing or related fields in your CV. Emphasise your ability to produce clear and accurate documentation, as well as any experience with specific therapeutic areas mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of regulatory processes and your attention to detail. Mention specific examples of past work that demonstrate your ability to meet client expectations and regulatory requirements.
Proofread Your Application: Ensure that your application is free from errors. Given the nature of the role, attention to detail is crucial. Double-check for spelling, grammar, and formatting issues before submitting your application.
How to prepare for a job interview at Meet Life Sciences
✨Understand Regulatory Requirements
Familiarise yourself with the specific regulatory requirements relevant to the role. Knowing the expectations of regulatory authorities will help you demonstrate your foundational understanding during the interview.
✨Showcase Your Writing Skills
Prepare samples of your previous regulatory documents, such as clinical study protocols or reports. Be ready to discuss your writing process and how you ensure clarity and accuracy in your work.
✨Demonstrate Critical Review Abilities
Be prepared to discuss how you critically assess client-supplied materials. Highlight your experience in reviewing protocols and data listings, and how you ensure documentation quality and data integrity.
✨Emphasise Collaboration and Communication
Since the role involves working closely with clients and team members, be ready to share examples of how you've effectively managed timelines and addressed issues in past projects. Clear communication is key!
