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Senior Regulatory Operations Associate

3+ years
Not Disclosed
10 June 3, 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

 

Job Title:

Senior Regulatory Operations Associate


Location:

Bangalore, Karnataka, India


Job Type:

Regular Full-time


Division:

Precision for Medicine — Clinical Solutions


Position Summary:

The Senior Regulatory Operations Associate provides vital administrative and operational support to the Regulatory Affairs department, managing regulatory document submissions, compliance, and process optimization. This role coordinates document redaction, submission package preparation, system management, and mentors junior staff while ensuring adherence to global regulatory guidelines including FDA, EMA, and Clinical Trial Regulation (CTR).


Key Responsibilities:

  • Upload, organize, and maintain regulatory documents in submission portals (e.g., CTIS, FDA eGateway, CESP).

  • Coordinate redaction of confidential information and liaise with vendors.

  • Prepare and review documents for regulatory submissions ensuring compliance.

  • Support document publishing in compliant formats (PDF, eCTD).

  • Maintain tracking logs for submission timelines and approvals.

  • Assist with audits and inspections.

  • Mentor junior regulatory administrators.

  • Collaborate cross-functionally and contribute to process improvements.


Qualifications:

  • Bachelor’s degree or equivalent experience.

  • Minimum 3 years in document management within clinical research, regulatory affairs, or related fields.

  • Knowledge of CTIS, eCTD publishing, global regulatory requirements (FDA, EMA, ICH, CTR).

  • Proficiency with document management systems (e.g., eTMF, Veeva Vault).

  • Strong organizational, communication, and problem-solving skills.