Regulatory Affairs Associate (Biologics)

Parexel


Date: 2 weeks ago
City: Remote, Remote
Contract type: Full time
Remote
Job Description

  • 4-6 yrs of experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
  • Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Support affiliates in updating local requirements based on guidance from regulatory agencies and input from affiliates/distributors.
  • Strong understanding of local and international regulatory guidelines.
  • Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products for filing in Regulated, Emerging and EU.
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Strong communications skills. Ability to work independently.
  • Effective communication and collaboration skills.

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