Regulatory Affairs Specialist for Life Sciences

1 month ago


Ahmedabad, Gujarat, India Lifelancer Full time
About the Role

We are seeking a skilled Regulatory Affairs Officer to join our team at Lifelancer. The ideal candidate will have hands-on experience with eCTD software, be proficient in Annual report preparation, and possess knowledge of regulatory requirements.

Key Responsibilities:
  • Facilitate Annual report preparation for various solid oral products
  • Review stability data, BPR documentation, and Human prescription drug labelling
  • Prepare labelling sections and facilitate section 1.14 module 1 of ANDA dossier creation
  • Contribute to Module 32s and 32p preparations
  • Possess hands-on experience with eCTD software (PharmaReddy) for SPL generation, registration, sequence creation, and uploading
  • Coordinate submissions via ESG
Requirements

The successful candidate will have:

  • Excellent understanding of Regulatory Affairs principles
  • Hands-on experience with eCTD software (PharmaReddy)
  • Strong analytical and problem-solving skills
  • Effective communication and collaboration abilities
What We Offer

Lifelancer is committed to providing a dynamic and supportive work environment. As a Regulatory Affairs Officer, you can expect:

  • A competitive salary of $85,000 - $110,000 per year, depending on location and experience
  • A comprehensive benefits package
  • Ongoing training and professional development opportunities
  • A collaborative and inclusive team environment

Join us at Lifelancer and take your career to the next level as a Regulatory Affairs Specialist.



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