Regulatory Publishing Consultant- 6 Month Fixed Term Contract

DLRC; Letchworth; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

DLRC Group in the UK is seeking a Regulatory Publishing Consultant to plan, format and compile Global regulatory submissions, ensuring quality, accuracy and submission readiness. The role includes liaison with regulatory authorities and developing publishing strategies for multiple projects in a fast-paced setting.

The successful candidate will have strong experience in EU/US submissions, familiarity with eCTD, and proficiency with MS Office and publishing tools.

Qualifications

• Degree in Life Sciences, Pharmacy, or equivalent.
• Eligible to work in the UK; fluent in English.
• Strong experience in regulatory publishing and submission management across EU and US.
• Proficiency with MS Office and publishing tools.

Responsibilities

• Assess priorities and set strategies to align with business needs
• Perform publishing activities including hyperlinking, bookmarking, quality control checks, troubleshooting, and document-level publishing tasks
• Ensure consistency, completeness, and adherence to regulatory agency guidance and internal SOPs
• Provide guidance on good documentation and lifecycle management practices
• Manage and prioritise multiple tasks in a fast-paced environment while maintaining submission timelines
• Stay current with eCTD guidance and global health authority submission requirements
• Prepare and format routine and complex Word and PDF documents
• Collaborate with project managers/leads to plan submission timelines
• Analyse regulatory changes for impact on projects and business strategy

Skills

Regulatory publishing

Submission management

EU/US submissions

MS Office

eCTD standards

Project coordination

Stakeholder liaison

Education

Life Sciences degree

Pharmacy degree

Tools

Word

Excel

Outlook

Adobe Acrobat

Job description

Established in 2005, the DLRC Group has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.

Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.

DLRC’s expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long‑term commitment to projects.

Regulatory Publishing Consultant

UK | Hybrid & Flexible Working- Initial 6 Month Fixed Term Contract

The Publishing Consultant will be responsible for planning, electronically formatting and compiling Global regulatory submissions to achieve client deliverables and ensure quality, accuracy, and submission readiness.

The opportunity:

Support regulatory projects on behalf of clients, including supervised liaison and negotiation with regulatory authorities.

Will provide excellent project support and develop clear, effective, and creative publishing strategies.

Key responsibilities:

• Assess priorities and set strategies to align with business needs
• Perform publishing activities including hyperlinking, bookmarking, quality control checks, troubleshooting, and document-level publishing tasks
• Ensure consistency, completeness, and adherence to regulatory agency guidance and internal SOPs
• Provide guidance on good documentation and lifecycle management practices
• Manage and prioritise multiple tasks in a fast-paced environment while maintaining submission timelines
• Stay current with eCTD guidance and global health authority submission requirements
• Prepare and format routine and complex Word and PDF documents
• Collaborate with project managers/leads to plan submission timelines
• Analyse regulatory changes for impact on projects and business strategy.

Technical Skills:

• Strong experience in regulatory publishing and submission management across EU and US
• Skilled in using publishing tools, document formatting, and compliance with eCTD standards
• Proficiency in MS Office (Word, Excel, Outlook, Adobe Acrobat)
• Experience leading publishing activities for major projects and developing publishing strategies
• Ability to advise clients on applicable regulations and prepare compliant submissions
• Familiarity with regulatory lifecycle management and SOP development
• Understanding of scope management, billing, and budget control for projects
• Experience in networking and supporting business development initiatives.

About you:

• Shares knowledge to close skills gaps and provides constructive feedback
• Adept at explaining complex scientific issues clearly, facilitating discussions, and building rapport
• Makes sound decisions independently, consults stakeholders early, and manages risks effectively
• Identifies opportunities for additional services, supports BD processes, and builds trusted client relationships
• Monitors workload, anticipates external factors, and adapts priorities to meet timelines
• Leads publishing activities, ensures compliance with regulatory requirements, and mentors others in publishing best practice
• Demonstrates and operates in line with the behaviours outlined in the Behavioural Competency Framework at the required level
• Degree in Life Sciences, Pharmacy, or equivalent
• Eligible to work in the UK; fluent in English.

We are a consultancy built on integrity, respect, and accountability. Our people are trusted to take ownership, supported to develop, and encouraged to think commercially.

We bring energy and enthusiasm to our work, collaborating closely with clients and partners to deliver practical, sustainable solutions. With flexible working and strong professional development pathways, we offer an environment where regulatory consultants can build influence, capability, and long‑term careers.