Global Regulatory Operations Publishing Manager / Fast-growing Biopharma / Flexible Working

3 days left

14 Apr 2021
14 May 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Global Regulatory Operations Publishing Manager - Biopharma

Flexible working arrangements - a combination of WFH and On-site.

Excellent opportunity for a Regulatory Operations, Submissions & Publishing Project Manager or possibly a top-end Senior Associate with a background in Regulatory Publishing, Submissions and Operations to join an established Submissions Team within a fast-growing Biopharma organisation located West of London; this company has Products in Development, at Registration stage and Post Marketing. If you an ambitious Regulatory Operations, Submissions & Publishing candidate seeking a fast-paced environment within a dynamic organisation, this represents the next stage in your career.

Team mentoring experience is desirable as are Project Managing and Leading skills.

Experience in the following is ideal: Veeva Vault; Liquent - ISI Toolbox or eCTDXPress; InsightPublisher; Adobe Acrobat (Toolbox) and MS Word. Docubridge or similar.

Knowledge of Regulatory Procedures is required: eCTD's - Development, MAA's, European Procedures - National/MRP, DCP and Centralised Procedure. Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals etc.

European and Global in geographic scope.

With a good grounding in Regulatory Publishing, Submissions and Operations you duties will include: Building and dispatching eCTD (CTD) lifecycle management submissions to meet meet current regulatory electronic document requirements; Accurately and timely updating internal working schedules related to assigned tasks; troubleshooting Document issues; work with appropriate Regulatory & Quality Control staff to ensure the checking of Submissions; familiarise with internal and external Publishing Standards.

Candidates with 5-6+ years Regulatory Publishing, Submissions and Operations experience should be suitable for this role.

The company is based West of London, but flexible working arrangements. A competitive salary package is offered to the right candidate including salary, bonus and leading benefits. It is generally accepted that this company is a superb organisation to learn and develop new Regulatory Operations skills.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07 447 977 330, or by, or submit an application by clicking Apply Now.

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