Chief Regulatory Document Developer

24 hours ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Writing Manager

This is a critical role that involves crafting and gaining approval for scientific and regulatory submission documents in line with global regulatory standards.

Key Responsibilities:
  • Develop regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents.
  • Conduct the formal review and approval of authored documents, following applicable standard operating procedures.
  • Oversee regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications.
  • Act as functional area lead on product teams.

You will also have the opportunity to:

  • Provide input for the Global Regulatory Plan and team goals.
  • Collaborate with contract and freelance writers.
  • Participate in the training and mentoring of junior medical writers.
  • Generate document timelines, with team input.
What We ExpectBasic Qualifications:
  • Doctoral degree OR
  • Master's degree and 4 to 6 years of directly related experience OR
  • Bachelor's degree and 6 to 8 years of directly related experience OR
  • Diploma and 10 to 12 years of directly related experience.
Preferred Qualifications:
  • Proficiency with word processing and other Microsoft Office Programs.
  • Significant knowledge of scientific/technical writing and editing, and of the overall clinical development process for new compounds.
  • Ability to understand and follow complex standard operating procedures (SOPs), guidance documents, and work instructions.
  • Understanding and application of principles, concepts, theories, and standards of the scientific/technical field.
  • Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidances and requirements.

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