Regulatory Operations Specialist

1 day ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

Job Title: Regulatory Operations Specialist

Key Responsibilities:
  • Coordinate administrative tasks to support the regulatory translation hub's functioning.
  • Manage access to relevant team members and keep access information updated.
  • Organize and archive documentation in team repositories, including dispatch emails and surveys as required.
  • Ensure timely renewal of licenses for translation-related software and indexing tools.
  • Update team lists and trackers, e.g., general job list, invoicing tracker, QC tracker, quality incidents tracker, email contact lists, CO job list tracker.
  • Assist team members with report and presentation preparation.

Financial Transactions Management

  • Manage invoices and create purchase orders on behalf of the Head of Regulatory Translations.
  • Maintain accurate invoice records.
  • Address invoicing-related matters with vendors or service providers.

Operational Support

  • In the absence of Regulatory Translations project managers or at their request, assign urgent jobs to appropriate vendors and perform quick format checks on outsourced translations before delivery.
  • Provide support with uploading and downloading files from relevant databases as necessary.
Qualifications and Skills:
  • Certified Administrative Professional (CAP) certification or an equivalent administrative degree.
  • Fluency in English (both written and spoken). Proficiency in other languages (optional)
  • At least 3 years of administrative experience, especially in Regulatory Affairs.
Required Skills:
  • Strong problem-solving skills.
  • Proficiency in Office tools (Excel a must).
  • Excellent organizational skills.
  • Adaptability.
  • Commitment to quality.
  • Good interpersonal skills.
  • Highly committed and team-oriented.
Desired Skills:
  • Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

Regulatory Compliance Specialist, Translation Operations, Regulatory Document Management, Clinical Research Coordinator

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