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Assistant General Manager

2+ years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 General Manager

Location: Dholka, India
Category: Regulatory Affairs Job
Company: Cadila Pharmaceuticals Ltd
Job Code: 18007614
Brand: Research & Development
Job Status: 1

Description:

Major Purpose of the Job:

  • Overall responsibility for submission and approval of marketing authorization applications in ICH regions—EU, UK, AUS, NZ, CA.

Responsibilities:

  • Review of eCTD dossiers, renewal applications, variations, and other post-marketing applications for ICH regions—EU, UK, AUS, NZ, CA.
  • Managing the response of deficiencies for ICH regions with timely initiation and discussion with cross-functional teams.
  • Provide regulatory strategy, guidelines, and support to cross-functional teams (R&D, Manufacturing, QA, QC, & ISBU).
  • Conduct feasibility assessments for projects proposed by ISBU for ICH markets as required.
  • Engage in collaborative interaction with clients and attend meetings for ongoing projects.
  • Participate in internal project management meetings for ongoing projects.
  • Liaise with regulatory agencies for clarifications and updates regarding submitted applications.
  • Plan, prioritize, and allocate projects to the team.
  • Review and approve technical documents from cross-functional teams related to registrations, submissions, and variations, including specifications, STPs, protocols, reports, MMD-I, labeling, and artwork.
  • Review and approve change controls, deviations, MMD-II, MDM, and SAP orders as required.
  • Stay updated with the development status of pipeline projects.
  • Track and maintain regulatory databases and project statuses for ongoing and planned submissions.
  • Monitor regulatory guidelines, regulatory forums, and agency websites at regular intervals.
  • Provide regulatory-related training across the department.