Regulatory Affairs Specialist

6 hours ago


Delhi, Delhi, India TransPerfect Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to lead our Regulatory Publishing team. The ideal candidate will have 6+ years of experience in eCTD Regulatory Publishing and strong knowledge of eCTD process.

Key Responsibilities:

  • Liaise with cross-functional teams to ensure compliance with government acts and regulations.
  • Oversee the publication of Clinical Study Reports, IND documents, NDA documents, and other regulatory documents.
  • Perform sampling QC on tasks completed by junior staff members.
  • Develop and maintain thorough understanding of publishing software, tools, processes, and output requirements.
  • Maintain accurate records and reports related to regulatory submissions.

Requirements:

  • Bachelor's degree or equivalent required.
  • Strong technical aptitude and problem-solving abilities.
  • Excellent communication and organizational skills.
  • Able to work under deadlines and modify work schedules as needed.
  • Adaptable and self-motivated individual.

Benefits:

  • Competitive salary: $100,000 - $120,000 per annum.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.


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