Parexel Hiring Remote Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate – Remote India

Description: Experienced Regulatory Affairs professionals required for Senior Regulatory Affairs Associate role at Parexel, Remote India.

Regulatory Affairs consulting plays a decisive role in ensuring clinical trials and innovative therapies move efficiently through complex regulatory pathways. Parexel is hiring a Senior Regulatory Affairs Associate for a remote, India-based role within its consulting division. This opportunity is ideal for experienced regulatory professionals with strong expertise in Indian clinical trial regulations who want to work on high-impact global programs while enjoying the flexibility of remote work.

Company Overview

Parexel is a globally respected clinical research organization and consulting partner to biopharmaceutical and medical device companies worldwide. Through its consulting practice, Parexel supports sponsors in navigating regulatory strategy, clinical development, and health authority interactions across global markets.

With a strong presence across North America, Europe, and Asia, Parexel is known for its scientific rigor, regulatory intelligence, and client-centric approach. The organization combines deep local regulatory expertise with global harmonization strategies to help products reach patients faster while maintaining full compliance.

Job Role & Responsibilities

The Senior Regulatory Affairs Associate role is part of Parexel Consulting and focuses on regulatory strategy execution, clinical trial submissions, and health authority interactions in India.

Core Regulatory Responsibilities

• Provide in-depth regulatory expertise on Indian clinical trial regulations, including NDCT Rules • Prepare, review, and submit Initial Clinical Trial Applications and amendments through the SUGAM portal • Manage timelines for query responses and ensure on-time regulatory submissions • Execute and maintain submission delivery plans and submission content plans • Prepare briefing materials, presentations, and documentation for Subject Expert Committee meetings • Manage and complete clinical trial registrations on the Clinical Trials Registry–India portal • Track and interpret Gazette notifications, guidelines, and regulatory updates • Provide regulatory advice and comments to internal teams, sponsors, and regulatory authorities

Stakeholder Management & Consulting Support

• Liaise with global sponsors and cross-functional internal teams • Support harmonization of Indian regulatory requirements with global regulatory expectations • Provide proactive status updates to stakeholders on submission progress and risks • Work independently while collaborating across multiple time zones • Mentor and guide junior regulatory team members

Eligibility / Qualifications

This role is suitable for experienced Regulatory Affairs professionals with strong India regulatory expertise.

Required qualifications:

• 4–7 years of experience in Regulatory Affairs with focus on Indian clinical trial regulations • Hands-on experience with SUGAM portal for CTA/iCTA submissions and amendments • Experience managing CTRI registrations and updates • Strong understanding of NDCT Rules and Indian Health Authority procedures • Ability to manage strict regulatory timelines and multiple submissions • Excellent written and verbal communication skills • Ability to work independently and across global time zones

Relevant educational background includes: MPharm, PharmD, MSc Life Sciences, Biotechnology, Clinical Research, Regulatory Affairs

Location & Salary

Job Location: Remote (India)

This is a full-time, remote position based in India. Salary details are not publicly disclosed; however, Parexel offers competitive compensation packages aligned with senior regulatory consulting roles.

Professionals can expect:

• Flexible remote working model • Exposure to global regulatory consulting projects • Opportunity to work directly with international sponsors • Long-term career growth within regulatory strategy and consulting

Application Process

Interested candidates can apply directly through the official Parexel careers portal using the link below:

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

Shortlisted candidates will be contacted by the recruitment team for further steps in the selection process.

Frequently Asked Questions

Is this a remote role?

Yes. This is a fully remote role based in India.

Is this role suitable for freshers?

No. This position requires 4–7 years of regulatory affairs experience.

What regulatory areas does this role focus on?

Indian clinical trial regulations, NDCT Rules, SUGAM submissions, and CTRI registrations.

Does the role involve global stakeholder interaction?

Yes. The role involves regular interaction with global sponsors and cross-functional teams.

Are mentoring responsibilities included?

Yes. Senior associates are expected to guide and mentor junior team members.

Category	Details
Company	Parexel
Vacancies	Senior Regulatory Affairs Associate
Required Education	MPharm, PharmD, MSc Life Sciences, Clinical Research
Experience	4–7 Years