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Associate - Cscc & Rm

2 years
Not Disclosed
10 Sept. 8, 2025
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: Associate – CSCC & RM


Job Summary

The Associate – CSCC & RM will be responsible for supporting regulatory affairs operations through accurate tracking, coordination, and documentation management. The role involves close collaboration with affiliates, vendors, and other stakeholders to ensure timely execution of requests, updates, and submissions in compliance with business and regulatory requirements.


Key Responsibilities

  • Create, compile, and distribute Product Quality Reports (PQRs) from the regulatory affairs system in a timely manner.

  • Coordinate with affiliates and stakeholders to gather information for tracking certificates and sample statuses.

  • Monitor progress on certificate and sample requests to ensure deadlines are met.

  • Liaise with registered vendors for document translations required for submissions, ensuring timely delivery to country affiliates.

  • Coordinate sample requests required for product registration with affiliates.

  • Assign tasks to relevant stakeholders through accurate workflow management, based on request categories.

  • Update and archive requests on SharePoint, ensuring global affiliates have visibility of request status.

  • Perform bulk updates in the regulatory affairs system as needed.

  • Provide operational support for additional business requirements as assigned.

  • Actively collaborate as a team player, demonstrating ownership and effective coordination with key stakeholders.


Qualifications & Competencies

  • Education: Bachelor’s degree in Biology, Chemistry, Pharmacy, Biosciences, or equivalent.

  • Experience: 6 months to 2 years of experience in regulatory affairs or related fields.

  • Skills:

    • Strong coordination and organizational skills.

    • Ability to manage multiple tasks and meet deadlines.

    • Proficiency in regulatory documentation and workflow tools (e.g., SharePoint, regulatory systems).

    • Effective communication and teamwork abilities.