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Regulatory Affairs Associate I

1-3 years
Not Disclosed
10 Sept. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 Associate I – RA Publishing

Date Posted:

September 12, 2025

Location:

Navi Mumbai, India, 400706

Company:

Teva Pharmaceuticals


Company Overview:

Teva Pharmaceuticals is committed to making health more affordable and accessible, helping millions globally live healthier lives. Operating in nearly 60 countries, Teva is a leading manufacturer of generic medicines and a producer of many WHO Essential Medicines.


Role Overview:

The Regulatory Affairs Associate I – RA Publishing participates in the publishing of regulatory submissions, ensuring 100% quality and adherence to submission timelines. This role serves as the primary interface with Regulatory Affairs Associates and contributes to efficient submission processes for multiple regions.


Key Responsibilities:

  • Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US, and Canada.

  • Handle post-approval submission publishing and ensure high-quality submission delivery to regulatory agencies.

  • Perform document-level publishing activities, troubleshoot document issues, and conduct quality control checks to ensure submission readiness.

  • Collaborate with scientific personnel for planning, preparation, and publishing.

  • Maintain working knowledge of internal and external publishing standards.

  • Stay updated on ICH and eCTD specifications/guidelines for regulatory submissions (eCTD, NeeS, paper).

  • Operate and maintain proficiency in technical systems such as Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator.


Qualifications & Experience:

  • Education: B. Pharm, M. Pharm, or Master of Life Sciences.

  • Experience: 1–3 years of relevant experience; regulatory publishing experience in EU and US markets preferred.

  • Skills & Competencies:

    • Excellent command of spoken and written English.

    • Sensitivity to the cultural diversity of a global organization.

    • Understanding of regulatory IT systems.


Reporting Line:

Reports to Manager – Regulatory Submission Management


Equal Employment Opportunity:

Teva Pharmaceuticals is committed to equal opportunity employment and a diverse, inclusive workplace. All accommodations for recruitment and selection are treated confidentially.