Position: Regulatory Writer – Entry Level
About the Role:
We’re looking for an Entry Level Regulatory Writer to join our growing team. In this role, you’ll research, write, and edit materials for regulatory submissions, working with experienced professionals who will guide you through the process. You’ll gain hands-on experience with regulatory documentation, clinical trial data, and submission processes from start to finish.
This is a fully remote position where you’ll work as part of a collaborative team, learning industry standards and best practices as you develop your skills in regulatory writing.
What You’ll Do:
• Author and compile regulatory applications and submissions, including correspondence, protocol amendments, safety reports, and related documents (with guidance and oversight)
• Research scientific and regulatory information to support writing projects
• Work with data management and clinical teams to review protocols and interpret clinical trial data
• Contribute to project timeline development and regulatory milestone planning
• Format and edit regulatory documentation according to guidelines and standards
• Support the timely preparation of regulatory submission documents
• Maintain project trackers and records as needed
• Assist other team members with writing, editing, and compilation of documents
• Ensure quality and accuracy of all written work in line with applicable regulations and company standards
• Perform general administrative duties as needed to support the team
Skills/background needed:
• Master’s degree in a life science, applied science, or communications field
• 1 year of medical, regulatory, or clinical writing experience (or equivalent training)
• Ability to write and edit clinical regulatory documents with supervision
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal abilities
• Ability to manage multiple projects and meet deadlines
• Comfortable working in a fast-paced, changing environment
• Ability to work both independently and as part of a team
• Analytical skills with the ability to interpret scientific and clinical data
What We Offer:
• Fully remote work – work from home with flexibility
• Comprehensive health coverage (medical, dental, vision) from day one
• Flexible time off and paid sick time
• 14 company-paid holidays
• Retirement plan with company contributions
• Life and disability insurance
• Paid parental leave
• Remote workspace and wellness reimbursement
• Employee assistance programme
• Career development and growth opportunities
• Opportunity to work with a global team on meaningful projects
• Full training provided – we’ll help you succeed from day one
Rate: Competitive entry-level pay, details shared upon application.
Contract length: Full-time
Location: Remote – open to applicants worldwide
We believe in building an inclusive and supportive work environment. We welcome applications from people of all backgrounds and encourage candidates from underrepresented groups to apply. We are an Equal Opportunity Employer committed to fair and equitable treatment in all employment practices.
Ready to get started? Submit your application below.