Associate Regulatory Affairs Specialist

20 hours ago

Gurgaon, Haryana, India beBeeregulatory Full time

Job Title: Associate Regulatory Affairs Specialist

This role offers the opportunity to join a dynamic team and contribute to the preparation of regulatory submissions, document management, and research. The ideal candidate will possess excellent communication skills, proficiency in Microsoft Office applications, and the ability to manage multiple projects simultaneously.

Responsibilities:
  • Document Management: Assist in the preparation and collection of country-specific administrative forms and regulatory submission documents, including INDs, NDAs/MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities.
  • Regulatory Research: Conduct research to identify precedents and support the preparation of orphan drug designation requests.
  • Tracker Maintenance: Maintain and update regulatory trackers, submission timelines, and status reports.
  • Documentation Archiving: Ensure proper archiving of submission documentation in compliance with internal SOPs.
  • Client Support: Provide assistance to clients, customers, or other stakeholders with general regulatory information.
  • Information Gathering: Gather information through files, records, and personal contacts to prepare detailed reports and compose routine correspondence.
Requirements:
  • Credentials: Master's degree in Pharmaceutical Sciences.
  • Experience: Minimum of 2 years of experience in a regulatory, quality, or document management support role.
  • Skillset: Strong interpersonal and communication skills, advanced proficiency in Microsoft Office applications, good time management and project management skills.

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