Regulatory Writer

JR United Kingdom; Bolton; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading company in life sciences is seeking a Regulatory Writer to produce high-quality regulatory documents. This remote role requires a detail-oriented candidate who can manage multiple projects, ensuring compliance with clients and regulatory expectations. Benefits include an unlimited holiday policy.

Benefits

Unlimited Holiday Policy

Qualifications

• Foundational understanding of regulatory submissions.
• Experience in producing regulatory documentation.
• Strong written and oral communication skills.

Responsibilities

• Author regulatory documents ensuring scientific accuracy.
• Adhere to standard operating procedures and regulatory processes.
• Communicate effectively with clients and team members.

Skills

Attention to detail

Scientific accuracy

Project management

Data integrity assessment

Technical writing

Job description

Social network you want to login/join with:

Regulatory Writer, Bolton, Greater Manchester

Client:

Meet Life Sciences

Location:

Bolton, Greater Manchester, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

3

Posted:

26.06.2025

Expiry Date:

10.08.2025

Job Description:

Regulatory Writer - remote

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
• Clinical trial authorisation (CTA) documents

BENEFITS

• Unlimited Holiday Policy (including office closure between Christmas and New Years)