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Global Regulatory Submission Publisher

Basel, Switzerland   •  Contract/Temporary, Full time


QLS are recruiting for a Global Regulatory Submission Publisher to join a project with a Global Pharmaceutical Company based in Basel on a contract basis for 12 months.

Remote working:
Hybrid or fully remote (needs to be based in Switzerland)

Role objectives:
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.).

Key Responsibilities:

  • 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.
  • Ensuring a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
  • Ensuring compliance to the requirements from regulatory agencies.
  • Maintaining the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.

Qualification:

  • BS in life sciences or a relevant discipline with min 5 years of professional work experience.
  • 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.
  • Effective interpersonal skills, strong written and oral communication and presentation skills.
  • 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.
  • Works independently and with minimal supervision.
  • Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly. Analytical skills and problem solving skills.
  • Ability to coordinate and work effectively with cross-functional teams
  • Languages: Fluent in English (Strong oral and written skills required). Additional language is an asset.

Apply:
Please could you send any correspondence in English. Please quote job reference 54775 in all correspondence.


You must have the right to work in Switzerland.

  • Agency: CK Group
  • Reference: 54775
  • Posted: 23rd November 2022
  • Expires: 21st December 2022

CK Group

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