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Regulatory Affairs Manager - Adc

13+ years
Not Disclosed
10 Dec. 30, 2024
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

Job Title: Regulatory Affairs Professional

Role Type: Experienced Individual Contributor
Work Supervision: Limited supervision
Area of Expertise: Regulatory Affairs


Main Purpose of Role

The Regulatory Affairs Professional is an experienced individual contributor who applies subject matter knowledge in regulatory affairs, working with limited supervision. The role requires a deep understanding of the regulatory process, the ability to manage product registration submissions, and the expertise to navigate regulatory agencies throughout a product's lifecycle.


Main Responsibilities

  • Product Registration: Lead the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports. Ensure all regulatory submissions are accurate and timely.
  • Regulatory Agency Interaction: Serve as the main point of contact with regulatory agencies to expedite the approval of pending registrations.
  • Product Lifecycle Liaison: Act as a regulatory liaison throughout the product lifecycle, ensuring compliance and maintaining regulatory affairs standards.
  • Regulatory Strategy and Risk Management: Participate in developing and implementing product plans, regulatory strategies, and risk management processes.
  • Approval and Compliance: Ensure timely approval of new drugs, biologics, or medical devices, and ensure the continued approval of marketed products.
  • Cross-functional Collaboration: Act as the regulatory representative to marketing, research teams, and regulatory agencies. Provide expertise and guidance on regulatory requirements, technical labeling, and manufacturing changes.
  • Advisory Role: Advise development and marketing teams on appropriate regulations, interpretations, and potential impacts of manufacturing changes and line extensions.

Qualifications

  • Education: Associate’s Degree (approximately 13 years of education) in a related field.

This role is pivotal in ensuring that products comply with regulatory standards and achieve timely approvals, facilitating smooth operations across product development, marketing, and ongoing compliance throughout the lifecycle of pharmaceutical or medical products.