Regulatory Affairs Associate

Vor 3 Tagen

Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

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Regulatory Affairs Associate

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Regulatory Affairs Associate for a
24-month contract (with possibility for extension) based in Basel, Switzerland.

Job purpose:

Provide operational support to RA Regions. Responsible for organization and coordination of business critical documents, required for regulatory submissions in rest of the world countries. In addition, responsible for managing legalization of these documents when required.

Main Responsibilities:

  • Support regulatory activities (New MAAs, line extensions, renewals, CMC changes, Safety Label Changes) in Rest of World countries, by ensuring timely and accurate availability of business critical documents, not provided as part of the core dossier
  • Manage and coordinate process for Apostille or legalization of business critical documents required to support regulatory activities in Rest of World countries
  • Manage relationship to external vendors providing legalization and notary services – act as Single Point of Contact with these vendors
  • Manage and coordinate process for Letters of Authorization, required by Health Authorities to support regulatory activities in Rest of World countries
  • Coordinate and facilitate timely delivery of business critical documents to CPOs worldwide
  • Manage tracking of all legalization and dispatch activities, ensuring accurate and timely oversight available to relevant business partners
  • Provide operational support to RA Regions, e.g. maintaining generic mailbox, maintaining archive, organizing meeting support, coordination of signatures
  • Provide training on declaration letters and legalization process to RA Regions and key stakeholders as needed
  • Provide additional operational support to RA MOW, as required

Qualifications and Experience:

  • Swiss working/residency permit and/or Swiss/EU-Citizenship required
  • English required; German is a plus
  • Bachelor's degree preferred
  • Proficient in MS Office, Teams , Outlook etc.
  • Strong communication, coordination, and planning abilities; reliable and proactive in addressing issues
  • Prior administrative experience, experience with HA document handling is a plus

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