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Assistant Manager Regulatory Affairs

10-15 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Assistant Manager Regulatory Affairs

Company: Torrent Pharmaceuticals

Location: Gandhinagar, Gujarat

Experience: 10 to 15 years

Qualification: M.Pharm / M.Sc.

Profile & Exposure:

  • EU Market – Pre and Post Approval

  • Formulation regulatory experience with various dosage forms like Solid Oral, Topicals, Solutions, Suspensions, Injectables, Ophthalmics, and Peptides

  • EU dossier compilation, especially for Module 1, 2, and 3

  • Hands-on experience with EU procedures like DCP, MRP, and National procedures

  • National phase handling for EU procedures

  • Post-approval variation compilation and filing with various EU agencies

  • Experience with eCTD compilation would be an added advantage

Application Details:
Interested candidates can share their CV at:
keyurnakum@torrentpharma.com