Senior Regulatory Affairs Specialist

20 hours ago


Vadodara, Gujarat, India Acme Generics Full time
Job Description

Acme Generics is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. This role involves ensuring compliance with regulatory guidelines and managing technical data requirements.

Key Responsibilities:
  1. We are looking for an individual who can compile, prepare, and review dossiers in CTD, ACTD formats, and country-specific documents as per regulatory guidelines of countries.
  2. The successful candidate will be responsible for coordinating with various departments (Production, Quality Assurance, Quality Control, Packaging department, and F & D) for technical data requirements.
  3. A strong understanding of ICH Guidelines (QSEM) and Common Technical Document (CTD) for the registration of pharmaceuticals for human use is required.
  4. The ideal candidate will be able to prepare and review SmPC, Package insert, and labeling information.
  5. An ability to file online applications for dossier submission in the US and EU is essential.
  6. Handling queries received from clients and MOH is also a critical aspect of this role.
Benefits

As a Senior Regulatory Affairs Specialist at Acme Generics, you will enjoy a competitive salary of approximately $120,000 annually, depending on experience. In addition to your base salary, you will receive benefits such as health insurance, retirement plans, and paid time off.



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