Regulatory Affairs Specialist

hace 6 días


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo
Regulatory Affairs Officer Job Description

We are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.

Responsibilities:
  • Contribute to the production of client administrative documents for regulatory submissions.
  • Compile regulatory dossiers in accordance with national requirements.
  • Manage and administer regulatory systems.
  • Track and document regulatory submissions and approvals.
  • Provide regulatory support to clients and associate companies.
  • Liaise with external regulatory authorities as required.
  • Review packaging texts and ensure compliance.
  • Review and format regulatory documents, including Summary of Product Characteristics and Patient Information Leaflets.
  • Provide ongoing regulatory support to the Regulatory Affairs Manager and project teams.
  • Contribute to data entry in PLG tools to measure KPIs and metrics.
  • Assist in the preparation of Standard Operating Procedures and Working Practice Documents.
  • Assist in the management of ProductLife Ltd's Quality Management System.
Requirements:
  • Bachelor's degree in a science-related field or equivalent experience.
  • 1-3 years of experience in Regulatory Affairs for the pharma industry.
  • Excellent English and Spanish language skills.
  • Strong organizational and interpersonal skills.
  • Ability to work well in an international and remote team.
  • Process-oriented with attention to detail.
  • Effective communication skills.
  • Good computer skills and ability to learn software.
  • Understanding of regulatory tracking database software and MS Office.


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