Parexel – Regulatory affairs Associate Vacancies

Parexel - Regulatory affairs Associate Vacancies
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Parexel Hiring Regulatory Affairs Associate – Remote Pharma Regulatory Jobs in India

Parexel is hiring for Regulatory Affairs Associate roles across India (Remote work opportunity). This is a full-time position for professionals with 2–4 years of experience in regulatory affairs, clinical trial submissions, and compliance with Indian and global regulatory frameworks.

This role is ideal for candidates looking to build a high-growth career in regulatory affairs, clinical research consulting, and global drug approval processes within a leading CRO.


Company Overview

Parexel is a globally recognized clinical research organization (CRO) and consulting firm that supports biopharmaceutical and medical device companies in bringing new therapies to market.

With deep expertise in regulatory consulting, clinical development, and market access, Parexel works with global sponsors to navigate complex regulatory pathways. The company is known for its scientific excellence, strong client partnerships, and flexible remote work culture.


Job Role & Responsibilities

As a Regulatory Affairs Associate, you will support regulatory strategy, submissions, and compliance for clinical trials and product approvals.

Core Responsibilities

  • Prepare and submit clinical trial applications (CTA/iCTA) through SUGAM portal
  • Manage regulatory submissions and amendments as per NDCT Rules
  • Coordinate with global sponsors and cross-functional teams
  • Prepare documentation and briefing materials for SEC meetings
  • Handle Clinical Trials Registry of India (CTRI) submissions and updates
  • Track regulatory timelines and ensure timely responses to queries
  • Maintain submission plans and provide regular status updates
  • Stay updated with regulatory guidelines, gazette notifications, and compliance requirements

Eligibility / Qualifications

  • Educational Qualification: B.Pharm, M.Pharm, Pharm.D, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry)
  • Experience: 2–4 years in regulatory affairs or clinical research
  • Strong knowledge of Indian regulatory guidelines (NDCT Rules)
  • Hands-on experience with SUGAM portal and CTRI submissions
  • Understanding of global regulatory frameworks and harmonization
  • Good communication and stakeholder management skills

Location & Salary

  • Job Location: India (Remote)
  • Work Mode: Work From Home
  • Salary Range: ₹6 LPA – ₹14 LPA (approximate based on regulatory affairs roles in CRO industry)

Application Process

Apply directly through the official Parexel careers page:

Apply Here: https://jobs.parexel.com/en/job/-/-/877/90571878512


Frequently Asked Questions (FAQs)

Is this role suitable for freshers?

No, this role requires 2–4 years of regulatory affairs experience.

What platforms are important for this role?

SUGAM portal and CTRI are key platforms for regulatory submissions in India.

Is this a remote pharma job?

Yes, this role is fully remote across India.

What career growth can I expect?

You can grow into Senior Regulatory Affairs Specialist, Regulatory Manager, or Global Regulatory Lead roles.


Summary

Category Details
Company Parexel
Vacancies Regulatory Affairs Associate
Required Education B.Pharm, M.Pharm, Pharm.D, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry)
Experience 2–4 years in regulatory affairs

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To apply for this job please visit jobs.parexel.com.



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