Senior Regulatory Publishing Associate / Submissions Management

Excellent opportunity for a Regulatory Associate with a background in Regulatory Publishing, Submissions and Operations to join an established Submissions Team within a large Pharma organisation located North of London. If you an ambitious junior Regulatory Publishing candidate seeking a fast-paced environment within a dynamic organisation, this represents the next stage in your career.

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

Some experience in the following is ideal: Liquent – InsightPublisher, or CSC/eCTDXPress; Adobe Acrobat (Toolbox) and MS Word. Docubridge or similar.

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 1-3 years Regulatory Publishing, Submissions and Operations experience should be suitable for this role.

The company is based just North of London. 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 julian@turnerregulatory.com, or submit an application by clicking Apply Now.