Global Regulatory Submission Publishing Associate (897287-MST)

Basel, Canton of Basel-Stadt (CH)
22 Feb 2021
02 Mar 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Entry level

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a Global Regulatory Submission Publishing Associate to be based in Basel for a 18-month contract position.

As a Global Regulatory Submission Publishing Associate you are accountable for all publishing, verification, coordination and dispatch of HA compliant, worldwide regulatory submissions in support of our clients global product portfolio.

Main Responsibilities:

  • Create, assemble and publish electronic submissions per regulatory requirements with a focus on maintenance submissions worldwide (variations, Response to List of Questions etc);
  • Coordinates internal publishing activities and liaises with cross functional teams and document authors to assist with timelines and deliverables related to submission document;
  • Conducts quality control review tasks,

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required;
  • Bachelor’s Degree in life sciences or a relevant discipline with 3-5 years of professional work experience in Pharma or related industry;
  • Familiar with regulatory requirements and good knowledge on regulatory submission format, particularly CTD/eCTD;
  • Strong interpersonal communication skills and ability to work effectively in cross-functional teams;
  • Proficiency with MS office and publishing software (e.g. eCTDXpress, DocuBridge, etc.);
  • Fluent in English (strong oral and written skills).

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