Regulatory Affairs Associate

Vor 3 Tagen

Basel, Basel-Stadt, Schweiz Actalent Vollzeit

Our client, a leading global pharmaceutical company, is looking for a
Regulatory Affairs Associate
to support key submission activities across international markets. This role is ideal for someone who enjoys coordination, thrives in a structured environment, and wants to contribute to bringing life‑changing medicines to patients worldwide.

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit

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

Must haves:

  • 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 RA administrative experience, experience with HA document handling is a plus.

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