Regulatory Affairs Specialist

2 weeks ago

Ahmedabad, Gujarat, India beBeeregulatory Full time ₹ 6,54,321 - ₹ 12,34,567

We are seeking an experienced Regulatory Affairs Specialist to join our dynamic team in Ahmedabad. This full-time position requires a candidate with a strong understanding of regulatory standards and processes.

About the Role
  • Manage regulatory submissions and ensure compliance.
  • Facilitate product registrations to support expansion into new markets.
Key Responsibilities
  • Review dossiers and queries for accuracy and compliance.
  • Maintain country-specific regulatory records.
  • Prepare dossiers for first-time submissions in new countries.
  • Collaborate with the plant team on technical documents.
Required Skills and Qualifications
  • In-depth knowledge of FDA Guidelines.
  • Proficiency in handling technical documents.
  • Strong analytical skills for data assessment.
  • Excellent communication skills for liaising with regulatory agencies.
Benefits
  • Ongoing professional development opportunities.
  • A dynamic and supportive work environment.

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