Planet Pharma
Regulatory Affairs Specialist
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Regulatory Operations Publishing Senior Associate | UK Remote | 12-Month Contract
I’m currently supporting a global pharmaceutical organisation with the search for a Regulatory Operations Publishing Senior Associate to join their team on a 12-month maternity cover contract.
The Role
This is a hands-on Regulatory Operations / Regulatory Publishing position, supporting the preparation and delivery of high-quality, compliant regulatory submissions to global health authorities. You’ll work closely with cross-functional submission teams, helping to plan, coordinate, publish and QC regulatory submissions, primarily in eCTD format.
Key Responsibilities
- Prepare and publish regulatory submissions for investigational and marketed products
- Support submissions including INDs, CTAs, NDAs, BLAs and MAAs
- Act as a Regulatory Publishing SME within cross-functional project teams
- Coordinate submission deliverables and track progress against submission plans
- Perform submission QC and support issue resolution
- Identify and escalate risks to submission timelines
- Support report publishing, QC and electronic sign-off
- Maintain regulatory records and data within RIM systems
- Contribute to process improvements, job aids and best practices
- Work across multiple projects and submissions simultaneously
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What we're looking for
- 2–4+ years' Regulatory Operations / Regulatory Publishing experience
- Hands-on experience creating and publishing eCTD submissions
- Experience supporting submissions to global Health Authorities
- Knowledge of FDA, EMA, Health Canada and ICH requirements
- Experience with an industry-recognised eCTD publishing tool
- Experience with an eSubmission gateway
- Strong understanding of submission QC, validation and issue resolution
- Excellent communication and stakeholder management skills
- Ability to work independently across multiple projects
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Desirable experience
Experience with any of the following would be advantageous:
- GlobalSubmit
- Lorenz
- DXC ToolBox
- Starting Point
- Veeva Vault / Veeva RIM
This is a great opportunity for an experienced Regulatory Operations / eCTD Publishing Professional looking for a fully remote UK contract within a global pharmaceutical environment.
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