Regulatory Affairs Specialist

hace 7 días

Mexicali, Baja California, México CSL Behring A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Analyst to join our team at CSL Behring. As a key member of our Global Regulatory Affairs team, you will play a critical role in ensuring the compliance of our products in the assigned region.

Key Responsibilities
  • Regulatory Coordination
    • Interface between distributors/regulatory agents, Global Regulatory Affairs, and Commercial Operations Intercontinental to ensure compliance with CSL standards and guidelines.
    • Responsible for optimal product compliance with approved regulatory status by supervising regulatory activities.
    • Responsible to obtain marketing authorizations according to registration plan.
    • Responsible to maintain marketing authorizations: prepare and support applications, variations license maintenance, labeling, and renewals documents according to local requirements.
  • Tender Operation Activities
    • Support tender submissions (bidding process, fulfillment) in close collaboration with Sales Managers and Supply Chain.
    • Responsible for tenders' complete regulatory compliance control (from tender announcement through product dispatch to the distribution market).
  • Team Support Activities
    • Review local dossier for NDA and renewal.
    • Variation handling of all appropriate markets: uploading to SharePoint, distribution to countries as required, and any other platform required.
    • Support of any upcoming project of the team (under supervision of the responsible team member).
    • Invoice management.
  • Strategy
    • Ensure strategies are aligned within Commercial Operations and follow priorities as communicated by the supervisor.
    • Contribute to strategic CSL Behring projects as project manager or team member, as required.
  • Customer Relations
    • Ensure appropriate, relevant, and timely training of distributors/regulatory agents on adherence to all applicable CSL Behring policies/procedures and guidelines.
    • Ensure and organize, in collaboration with the supervisor, that Registration Agreements and/or Confidential Agreements are in place with distributors/regulatory agents for the assigned region.
    • Facilitate mutual understanding and solution finding of country-specific matters versus CSL Behring global interests.
  • Reporting & Communication
    • Weekly oral management reporting of key issues (Jour Fix).
    • Consolidated written monthly report on key issues and progress.
    • Active participation in team meetings, trainings, and workshops.

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