Job Description

Description :

We are currently looking for a Publisher. Reporting directly to the Manager, Regulatory Labelling and Operations, the Publisher is responsible for producing regulatory submissions of the highest quality standards, in compliance with ICH and regional format requirements. working closely with associates across all regulatory affairs departments at Pharmascience, he/she is accountable for the timely delivery of published and validated regulatory submissions that meet both internal and external electronic & paper format requirements. the Publisher ensures that both the production and lifecycle management of regulatory documents and submissions are carried out diligently, according to standard internal procedures as well as ICH and regional guidelines.

RESPONSABILITIES & DUTIES

Regulatory Document Management :

• Ensure regulatory documents are properly formatted as per requirements for electronic submissions & internal standards
• Perform check-in of new documents into the Document Management System (DMS)
• Ensure document DMS attributes consistently comply with internal operating standards
• Accountable for the proper lifecycle management (LCM) of documents in the DMS
• File and Manage key regulatory documents as per internal requirements

Regulatory Submission Compilation :

• Diligently compile regulatory submissions using the Submission Management System (SMS)
• Ensure submission structures produced using the SMS meet internal specifications as defined by the internal clients (other Regulatory Affairs departments at Pharmascience)
• Ensure submission structures produced using the SMS meet regional and ICH specifications for regulatory submissions
• Ensure submission attributes consistently comply with regional and ICH specifications for regulatory submissions
• Accountable for the proper lifecycle management of submissions in the SMS as per regional, ICH and internal standards for submission LCM

Publishing, Validation & Filing :

• Publish & deliver regulatory submissions in the proper format as specified in the internal client requests (from other Regulatory Affairs departments at Pharmascience) paper, CD-Rom, online gateway, etc ...
• Perform validation of all published output and ensure that all submissions pass validation as per regional, ICH and internal standards
• Accountable for the timely completion of all deliverables requested by internal clients ( other Regulatory Affairs departments)
• Remain up to date with regards to ICH & all regional standards relevant to the company for electronic regulatory activities
• Properly manage personal timelines and workload distribution between short term and long-term deliverables such that all project deadlines are respected
• Responsible for filing of eCTD outputs to different health authorities using the proper electronic submission gateway

Skills, knowledge and abilities :

• Bilingual (English & French}
• Knowledge of the drug development & regulatory submission processes is an asset
• Functional & comfortable with computer applications (MS Office, Adobe Pro, etc.)
• Meticulous, strict attention to detail
• Strong team spirit and sense of customer service
• Ability to work under pressure and tight timelines
• Ability to multitask in a fast-paced environment
• Self learner with a proven ability to adapt to changing demands

Education : Attestation of Collegial Studies

Experience : 1 years: in the Pharmaceutical Industry, or in the Document I Regulatory Submission Management (EDMS/SMS) Software Industry

Pharmascience