Regulatory Affairs Specialist

7 days ago


Gandhinagar, Gujarat, India Lifelancer Full time

About the Role:

We are seeking an experienced Regulatory Affairs Specialist to join our team at Lifelancer. In this role, you will be responsible for preparing and submitting regulatory documents to ensure compliance with international guidelines.

Responsibilities:

  • Dossier Preparation: Prepare dossiers in accordance with the ACTD & CTD (Module I, II, III, IV and V) guidelines.
  • Technical Document Review: Review technical documents such as raw material and finished product specifications, manufacturing processes, product development reports, stability reports, process validations, and analytical method validations.
  • Regulatory Query Response: Respond to regulatory queries from various authorities.
  • Drug Master File Review: Review Drug Master Files to ensure accuracy and completeness.

Requirements:

  • Bachelor's or Master's degree in Pharmacy or a related field.
  • At least 2-5 years of experience in regulatory affairs.
  • Strong knowledge of regulatory requirements and guidelines.
  • Excellent communication and project management skills.

What We Offer:

  • A competitive estimated salary range of $60,000 - $90,000 per year, depending on experience.
  • The opportunity to work with a leading talent-hiring platform in Life Sciences and IT.
  • A dynamic and supportive work environment.

About Us:

Lifelancer is a talent-hiring platform that connects professionals with opportunities in pharmaceuticals, biotechnology, health sciences, and IT. Our mission is to provide innovative solutions for talent acquisition and management.



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