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Global Regulatory Submission Publisher – (5088-LBD)
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Global Regulatory Submission Publisher for 24 month contract role based in Basel, Switzerland. The stat date is: 05.12.2022 until 31.12.2024.
This role is an individual contributor position in GDD Regulatory Affairs Operations accountable for all publishing, verification, dispatch and coordination of HA compliant, worldwide regulatory submissions in support of NVS global product portfolios.
- Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool) and dispatch activities related to regulatory submissions (i.e., INDs, BLAs/NDAs, MAAs, HA A to Qs, Global Labeling, Annual Reports, etc.).
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements US, EU, LACan, MOW).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high-quality submissions.
- Comply with and actively apply internal work practices and guidelines.
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
Qualifications and Experience:
- Swiss working/residency permit and/or Swiss/EU-Citizenship required
- BS in life sciences or a relevant discipline with min 5 years of professional work
- Fluent in English (Strong oral and written skills required). Additional language is an
- 5-8 years submission publishing experience in Pharma or related industry.
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Strong skills and Publishing and Validation
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Working knowledge of regulatory affairs.
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