Regulatory Affairs Expert for Pharmaceutical Registration

3 weeks ago


Rajkot, Gujarat, India Acme Generics Full time
About the Role

Acme Generics is seeking an experienced Regulatory Affairs Officer to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory guidelines and facilitating the registration of pharmaceuticals for human use.

Key Responsibilities
  • Regulatory Compliance: Compile, prepare, and review dossiers in CTD, ACTD formats, and country-specific requirements as per regulatory guidelines.
  • Cross-Functional Coordination: Collaborate with departments (Production, Quality Assurance, Quality Control, Packaging, and F&D) to gather technical data.
  • ICH Guidelines: Knowledge/exposure to ICH Guidelines (QSEM) required for Common Technical Document (CTD) preparation.
  • Labeling and Documentation: Prepare and review SmPC, package inserts, and labeling information.
  • Dossier Submission: File online applications for dossier submissions in the US.
  • Query Handling: Respond to client and MOH queries as received.
About You

We are looking for a highly organized and detail-oriented individual with excellent communication skills. Your expertise in regulatory affairs, particularly in pharmaceutical registration, will be invaluable in this role. If you have a passion for ensuring compliance and working collaboratively with cross-functional teams, we encourage you to apply.

What We Offer

As a valued member of our team, you can expect a competitive salary range of $80,000 - 100,000 per annum, depending on experience. Our comprehensive benefits package includes health insurance, retirement savings plan, and paid time off.



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