PAREXEL Hiring: Senior Regulatory Affairs Associate – CMC Biologics (Remote / India)

PAREXEL, a global biopharmaceutical services provider and contract research organization, is inviting applications for the position of Senior Regulatory Affairs Associate – CMC Biologics. This is a fully remote position based in India, supporting global lifecycle management and Chemistry, Manufacturing, and Controls (CMC) submissions for biologics and small molecules.

Position Summary

Parameter	Details
Organization	PAREXEL International
Job Role	Senior Regulatory Affairs Associate – CMC Biologics
Job ID	R0000039988
Work Location	Remote, India
Functional Area	Regulatory Affairs / CMC Consulting
Employment Type	Full-Time
Application Deadline	10 October 2026

Candidate Profile & Eligibility

Academic Background:
- Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences, Chemistry, Biotechnology, or an allied scientific discipline.
- Master’s degree (M.Pharm / M.Sc.) is preferred.
Core Experience:
- Demonstrated track record managing the regulatory lifecycle of approved products, including small molecules and biologics (vaccines, monoclonal antibodies) across major global markets.
- Working familiarity with EU and US post-approval regulatory frameworks, variations, and procedures (knowledge of Rest of World/ROW regulations is advantageous).
- Familiarity with Regulatory Information Management Systems (RIMS) such as Veeva Vault.
- Exposure to EU QRD templates, European Commission excipient guidelines, and Company Core Data Sheets (CCDS).

Key Job Responsibilities

CMC Submissions & Authoring: Author and review CMC sections of Marketing Authorization Applications (MAAs), renewals (Modules 1, 2, and 3), annual reports, site registrations, and variations (DCP, MRP, and National procedures in the EU).
Health Authority Queries: Draft comprehensive responses to CMC-related queries from Health Authorities (HAs).
Variations & Grouping: Compile and submit dossiers for complex variation procedures, including Super Grouping, Grouping, and Work-Sharing submissions.
Compliance & Technical Review: Conduct regulatory evaluations of Drug Master Files (DMFs), manufacturing batch records, release specifications, and stability protocols.
Change Control Assessments: Perform regulatory impact assessments for proposed manufacturing/quality change controls across global filings.
Labeling Maintenance: Draft and update product labeling content for EU, US, Canada, and ANZ markets in line with PRAC and CMDh guidance.

Application Procedure

Candidates matching the eligibility criteria should submit their application directly through the PAREXEL Careers portal using Job ID: R0000039988.