Paraxel Hiring for Regulatory Affairs Associate Role: RA Jobs 2026

Parexel, a globally recognized leader in the CRO industry, is hiring Regulatory Affairs Associate (CMC) professionals across Bengaluru and Hyderabad, with both onsite and remote work options available. This role is an excellent fit for candidates with hands‑on experience in Regulatory Affairs – Chemistry, Manufacturing & Controls (CMC) who are looking to expand their expertise in global drug development processes.

As part of Parexel’s Regulatory Affairs team, you will gain exposure to EU regulatory submissions, MAA lifecycle management, dossier compilation/authoring, and regulatory strategy activities.
Professionals with experience in EU procedures, CMC documentation, submission planning, and health authority interactions will find strong career advancement opportunities in this role.

This position offers not just global visibility but also structured learning, cross‑functional collaboration, and the chance to contribute to high‑impact regulatory deliverables within one of the world’s top clinical research organizations

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Job Overview

• Position: Regulatory Affairs Associate
• Department: Regulatory affairs
• Location: Bengaluru, Hyderabad (Remote available)
• Experience: 2 to 6 Years
• Qualification: B.Pharm, M.Pharm,M.Sc
• Job Type: Full-Time

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Key Responsibilities – Regulatory Affairs Associate at Paraxel

• Understand Global Regulatory Frameworks: Gain a thorough understanding of regulatory expectations, regional trends, and application procedures for both small molecules and biologics across global markets.
• Provide Regulatory Input for CMC Deliverables: Support assigned deliverables by offering regulatory insights on procedural and CMC documentation requirements defined by various Health Authorities (HAs), including:
• Submission delivery strategy
• Document review and assessment
• Analysis of regulatory pathways, procedures, and special designations relevant to product development, approvals, and lifecycle extensions
• Cross‑Functional Collaboration: Work closely with cross‑functional teams—such as manufacturing, quality, medical, and regulatory counterparts—aligned with the assigned product responsibilities.
• Manage Submission Plans: Develop, track, and maintain submission delivery plans and content plans, while proactively updating stakeholders on timelines, risks, and progress.
• Dossier Authoring: Prepare and author CMC dossier sections required due to changes in approved Marketing Authorization Applications (MAAs), ensuring accuracy and compliance with regulatory expectations.
• Change Management Knowledge: Evaluate and document changes according to country‑specific regulatory guidelines, understanding how each region handles CMC variations.
• EU Lifecycle Management (Preferred): Experience in managing regulatory lifecycle activities—such as variations, renewals, and updates—within the EU regulatory framework is highly desirable.
• Health Authority Interaction: Review and submit CMC dossiers, respond to Health Authority queries, and participate in HA negotiations to support timely approvals.
• Cross‑Functional Business Support: Collaborate with local regulatory teams, medical affairs, marketing, and market access to assess the impact of CMC changes on product availability, labeling, and commercial strategy.

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Required Skills & Qualifications

Educational Background:

• M.Pharm / B.Pharm
• MSc in Life Sciences, Chemistry, or Biotechnology
• Candidates with a related Regulatory Sciences background are also suitable.

Relevant Experience:
Hands‑on experience in Regulatory Affairs – CMC, including exposure to regulatory submissions, technical documentation, and product lifecycle activities.

Knowledge of EU Regulatory Procedures:
Solid understanding of EU regulatory pathways, including variations, renewals, CMC updates, and approval processes.

MAA Lifecycle Management:
Experience handling Marketing Authorization Application (MAA) lifecycle activities such as updates, change control submissions, and ongoing maintenance.

Change Evaluation Expertise:
Understanding of country‑specific guidelines for evaluating CMC changes and preparing appropriate regulatory justifications.

Documentation & Dossier Skills:
Strong capability in CMC dossier authoring, reviewing regulatory documents, and ensuring accuracy and compliance with global standards.

Shift Flexibility:
Willingness to work in EU shifts, supporting European regulatory timelines and project demands.

Why Join Paraxel?

Joining Parexel means becoming part of one of the world’s most respected and trusted global CROs, known for its scientific expertise, regulatory leadership, and commitment to improving patient access to life‑changing therapies. As a Regulatory Affairs professional—especially in CMC—Parexel offers an environment where your work genuinely influences global healthcare outcomes.

How to Apply

Interested candidates should apply only through the official company career website using the link provided below.

Important Disclaimer

This job post is shared for informational purposes only, based on publicly available job details. Candidates are advised to verify eligibility, job responsibilities, and application procedures from the official IQVIA website before applying.

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FAQ – Regulatory Affairs Associate at Paraxel

1. What does a Regulatory Affairs Associate (CMC) do at Parexel?

A Regulatory Affairs Associate (CMC) supports CMC documentation, EU submissions, MAA lifecycle management, regulatory strategy, dossier authoring, and coordination with cross‑functional teams to ensure compliance with global regulatory requirements.

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2. What qualifications are required for this role?

Candidates should have an M.Pharm, B.Pharm, or MSc in Life Sciences, Chemistry, Biotechnology, or a related regulatory sciences background.

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3. How much experience is needed?

Relevant experience in Regulatory Affairs – CMC, including exposure to EU procedures, dossier authoring, and lifecycle management, is required. Experience working with Health Authorities is a plus.

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4. Is EU regulatory knowledge important?

Yes. Understanding EU regulatory procedures, variation filings, MAA lifecycle requirements, and change control guidelines is highly desirable for this role.

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5. Will I be involved in dossier writing?

Absolutely. A key part of the role involves authoring and reviewing CMC dossier sections, especially those linked to changes in approved MAAs.