Instagram
youtube
Facebook

Regulatory Affairs Manager - Adc

3+ years
Not Disclosed
10 March 10, 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

 

Regulatory Affairs Manager - ADC

Location: India - Mumbai
Category: Regulatory Affairs

Main Purpose of Role:

An experienced professional and individual contributor working under limited supervision. Applies subject matter expertise in Regulatory Affairs, demonstrating the ability to address specific regulatory needs and requirements.

Main Responsibilities:

  • Develop product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
  • Interact with regulatory agencies to expedite approval of pending registrations.
  • Serve as a regulatory liaison throughout the product lifecycle.
  • Participate in product plan development, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
  • Ensure timely approval of new drugs, biologics, or medical devices, as well as continued approval of marketed products.
  • Act as a regulatory representative to marketing, research teams, and regulatory agencies.
  • Advise development and marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory interpretations.

Qualifications:

  • Education: Associate’s Degree (± 13 years)