Regulatory Business Analyst (eCTD/CMC) – Healthcare/Life Sciences - £4
Posted Today by Totaljobs
£400 Per day
Outside
Remote
The City, City of London (EC3), EC3V 9DU
Summary: The Regulatory Business Analyst will lead business analysis activities within a healthcare client's regulatory intelligence program, focusing on translating complex regulatory requirements into actionable solutions. This role requires collaboration with regulatory affairs and operations stakeholders to enhance compliance and efficiency across the organization. The position is remote, with occasional travel to the client's London office, and is offered as an initial 2-month rolling contract. The role is classified as outside IR35 with a daily rate of £400.
Key Responsibilities:
- Lead requirements gathering and documentation with regulatory affairs and operations stakeholders.
- Translate regulatory requirements into user stories, functional specs, and process workflows using Agile methodologies.
- Support the full regulatory intelligence lifecycle — from capture and curation through to consumption.
- Drive implementation of regulatory intelligence platforms and SaaS solutions, including UAT and validation.
- Analyse global regulatory updates and perform gap analysis to define improved future-state processes.
- Work across eCTD submissions, labeling updates, and CMC variation processes.
Key Skills:
- Strong Business Analysis experience within a life sciences or pharmaceutical environment.
- Solid understanding of global regulatory standards and compliance requirements.
- Hands-on experience with Agile delivery, user story writing, and cross-functional stakeholder management.
- Excellent process mapping and documentation skills.
- Familiarity with regulatory intelligence platforms and a keen interest in automation and AI-driven solutions.
- Excellent communication skills with the ability to manage stakeholders of all levels.
Salary (Rate): £400 daily
City: The City, City of London (EC3)
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Regulatory Business Analyst (eCTD/CMC) – Healthcare/Life Sciences - £400 (Outside IR35) – Remote
Ventula Consulting United Kingdom (Remote)
Leading Healthcare client now requires an experienced Regulatory Business Analyst to lead business analysis activities across their regulatory intelligence programme. You'll sit at the intersection of regulatory affairs, technology, and operations — translating complex regulatory requirements into actionable solutions that drive compliance and efficiency across a global business.
What you'll do
- Lead requirements gathering and documentation with regulatory affairs and operations stakeholders.
- Translate regulatory requirements into user stories, functional specs, and process workflows using Agile methodologies.
- Support the full regulatory intelligence lifecycle — from capture and curation through to consumption.
- Drive implementation of regulatory intelligence platforms and SaaS solutions, including UAT and validation.
- Analyse global regulatory updates and perform gap analysis to define improved future-state processes.
- Work across eCTD submissions, labeling updates, and CMC variation processes.
What we're looking for
- Strong Business Analysis experience within a life sciences or pharmaceutical environment.
- Solid understanding of global regulatory standards and compliance requirements.
- Hands-on experience with Agile delivery, user story writing, and cross-functional stakeholder management.
- Excellent process mapping and documentation skills.
- Familiarity with regulatory intelligence platforms and a keen interest in automation and AI-driven solutions.
- Excellent communication skills with the ability to manage stakeholders of all levels.
This is an initial 2-month contract role (rolling) which provides a daily rate of £400 Outside IR35. In terms of working structure, this is remote with occasional travel to our clients London office.