Regulatory Affairs Specialist

2 days ago


Ahmedabad, Gujarat, India Acme Generics Full time
Job Title: Regulatory Affairs Officer

Company Overview:

At Acme Generics, we are committed to delivering high-quality generic medicines to the market. As a Regulatory Affairs Officer, you will play a crucial role in ensuring that our products meet regulatory requirements and comply with global standards.

Job Description:

  • We are seeking a highly motivated and experienced Regulatory Affairs Officer to join our team. In this role, you will be responsible for compiling, preparing, and reviewing dossiers in CTD and ACTD formats, as well as coordinating with internal departments to ensure technical data requirements are met.
  • You will have knowledge of ICH Guidelines (QSEM) and be able to prepare and review SmPCs, package inserts, and labeling information.
  • Your expertise in dossier submission and handling queries from clients and MOH is essential to this role.

Required Skills and Qualifications:

  • Minimum 5 years of experience in regulatory affairs
  • Knowledge of ICH Guidelines (QSEM)
  • Ability to work independently and collaboratively as part of a team
  • Excellent communication and organizational skills

Benefits:

  • Competitive salary range: $80,000 - $110,000 per annum
  • Ongoing professional development opportunities
  • A dynamic and supportive work environment

Others:

Please note that this job description is subject to change based on business needs. We thank all applicants for their interest; however, only those selected for an interview will be contacted.



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