Regulatory Publishing Operations Manager

Our client is a global multinational company leading in pharmaceutical sector.

in order to empower the Italian structure we are looking for a Regulatory Publishing Operations Manager who reporting directly to the Head of Global Regulatory Affairs.

The figure will manage the publishing and electronic submission process and the relevant staff in EU/USA and manage the external publishing contractors.

The resource will support the Insight Manager tracking system, the Expresso Document Management system and the Artwork Workflow System.

Develop and maintain processes and process documents for all the RA electronic systems and be the trainer on these systems across the different RA units. He/she will plan, prepare and publish submission documents (MAA, variations, NDA, sNDA, INDs, Amendments, Annual Reports, IMPD.) for both electronic and paper submissions to FDA, Health Canada, and EU/ROW Regulatory Agencies.

He/she will track and archive regulatory documents and submissions, both electronic and paper.

He/she will perform a quality check of documents received from other departments such as R&D, Quality, Clinical to ensure use of standards, templates and procedures, proofread, review and edit documents for grammar, accuracy, and consistency
Format documents for submission including hyperlinking and bookmarking.

The ideal candidate have a scientific background and a previous experience in the role (minimum 5 years).

Complete the profile an advanced understanding of publishing, document management and tracking systems, understanding of eCTD submission requirements, consolidated experience compiling electronic submissions in e-CTD format, cognizant of FDA, EMA and other Health Agency administrative guidelines and an experience with submission publishing software (formatting, conversions, bookmarking, linking, document verification, uploading).

Excellent english is mandatory.

Location: Milan

After reading the obligatory information regarding privacy laws on, we invite you to send your CV in Word, specifying the reference number of the position in question (Rif. 915371) together with the agreement for access to your personal information, according to the law ex D.LGS. 196/03. Aut. Min. N. 13/I/0007145/03.04 del 1 Aprile 2008


Tipologia di contratto:
Tempo indeterminato
Healthcare & Medical
Sede di lavoro
Life Sciences
Data di chiusura
20 May 2019
Candidati ora

Consulente di riferimento

Il Consulente Flaminia Gentile, è il nostro esperto che gestisce questa opportunità di lavoro, con sede a 20122 Milano

Corso Italia, 13, 20122 Milano, Italy

Telefono: +3902888931