- Degree in Sciences with 3+ years regulatory publishing experin
- Experience supporting eCTD in Canada
- Experience in supporting CTA and their requirements
- Provide regional or global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.
- Manage regional submissions as a lead publisher and support global submissions
- Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving timelines.
- Proactively collect necessary information from the Submission Team, and plan all submission management related activities.
- Proactively communicate with cross-functional colleagues on submission requirements including eCTD
- Liaise with global regulatory affairs staff regarding technical/format requirements on submission deliverables.
- Perform quality checking of documents and regulatory submissions to ensure compliance with style and submission-ready standards.
- Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools.
- Ensure printing and distribution of regulatory submissions, paper and electronic, as required.
- Bachelor’s degree or relevant equivalent experience
- Three years pharmaceutical experience in a regulatory environment.
- Two to four years experience with information management, document management technology, and electronic publishing software (Insight Publisher is an asset).
- Expertise in drug development, including knowledge of the contents/ formatting of regulatory submissions and product life-cycle and how other functions contribute to regulatory submissions
- Knowledge of regulatory authorities requirements on electronic submissions in Canada. Knowledge in also other regions an asset (e.g., US, EU, MEA, etc.)
- Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role
- Working in partnership with publishing vendors
- Dossier and Submission related Regulatory Guidance for CANADA
- Successful submission and maintenance of marketing applications
Senior Regulatory Submissions Publisher - ContractToronto, ON, Canada
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SENIOR REGULATORY SUBMISSIONS PUBLISHER - Contract
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001462
Date Posted: 23/11/2019