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Regulatory Affairs Manager - Adc

5+ years
Not Disclosed
10 Dec. 16, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Regulatory Affairs Manager - ADC
Location: India - Mumbai
Category: Regulatory Affairs


Main Purpose of Role:
The Regulatory Affairs Manager is an experienced individual contributor, working under limited supervision, who applies subject matter knowledge in Regulatory Affairs. The role requires the ability to apply regulatory expertise to meet specific needs and requirements for product approval and lifecycle management.

Main Responsibilities:

  • Direct the development of product registration submissions, progress reports, amendments, supplements, and periodic experience reports.
  • Engage with regulatory agencies to expedite approval for pending registrations.
  • Act as a regulatory liaison throughout the product lifecycle, ensuring timely approvals for new drugs, biologics, and medical devices, as well as the continued approval of marketed products.
  • Collaborate with marketing, research, and regulatory teams to develop product plans and strategies, focusing on regulatory compliance, risk management, and chemistry manufacturing controls (CMC).
  • Advise development and marketing teams on manufacturing changes, technical labeling, and regulations and interpretations relevant to product compliance.

Qualifications:

  • Education: Associates Degree (± 13 years)