Parexel Work from home Hiring Regulatory Affairs Consultant

Parexel Hiring Regulatory Affairs Consultant (Remote) | Senior Pharma Regulatory Strategy Role

Looking to step into a high-impact regulatory affairs consulting role? Parexel is hiring experienced professionals for the position of Regulatory Affairs Consultant in a remote setup across India. This opportunity is designed for senior-level candidates with 7–10 years of experience in global regulatory affairs, lifecycle management, and CMC submissions.

This role offers direct exposure to global markets including the US, EU, Japan, Canada, Switzerland, and Australia, making it a premium career opportunity in regulatory strategy, drug development consulting, and global submissions.

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Company Overview

Parexel is a leading global clinical research organization (CRO) and consulting firm that supports biopharmaceutical and medical device companies in navigating complex regulatory environments. With decades of industry experience, Parexel is known for delivering regulatory consulting, clinical development, and market access solutions.

The company partners with global clients to accelerate product approvals and ensure compliance across multiple regulatory jurisdictions, making it a trusted name in regulatory affairs and clinical research consulting.

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Job Role & Responsibilities

As a Regulatory Affairs Consultant, you will lead and support global regulatory strategy, submission planning, and lifecycle management activities.

Key Responsibilities:

• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (Biologicals,  Vaccines, ) in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
• Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
• Working knowledge of US, EU, Japan, Canada, Switzerland, Australia regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries, and author responses to HA requests
• Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
• Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
•  Authoring CMC component for marketed products, of Annual Reports, Variations, expansions, site transfers, Renewals in EU (Type IA/IB/II/IAIN), and US, Canada, Switzerland and RoW markets.

• Evaluation of change controls and deviations and identification of required documentation and strategy for US, EU, Japan, Canada, Switzerland, Australia submissions and other markets.

• Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
• Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.

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Eligibility / Qualifications

Educational Background:

B.Pharmacy, M.Pharmacy, Pharm.D, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Advanced Degree (PhD preferred)

Experience Required:

• 7–10 years of experience in regulatory affairs or regulatory consulting
• Experience in lifecycle management of biologics, vaccines, and pharmaceutical products
• Strong exposure to US, EU, and global regulatory frameworks
• Experience in CMC documentation and submissions

Skills Required:

• Strong knowledge of global regulatory guidelines and submission processes
• Expertise in regulatory strategy development and execution
• Excellent communication and stakeholder management skills
• Ability to work independently in a remote environment
• Strong analytical and problem-solving capabilities

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Location & Salary

• Location: Remote (India)
• Job Type: Full-time
• Salary: High-paying package based on experience and expertise

This role is among the most premium and high-demand positions in regulatory affairs, offering global exposure, consulting experience, and strong earning potential.

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Application Process

Interested candidates can apply through the official Parexel careers portal:

Apply Here: https://jobs.parexel.com/en/job/-/-/877/91080165264

Candidates are advised to apply early due to the competitive nature of senior regulatory consulting roles.

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Why This Role Matters in Healthcare

Regulatory Affairs Consultants play a critical role in bringing new drugs and medical devices to market. By developing global regulatory strategies and ensuring compliance, this role directly impacts patient access to innovative and life-saving therapies.

Working in this position allows professionals to influence regulatory pathways across multiple international markets and contribute to global healthcare advancement.

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Frequently Asked Questions (FAQs)

1. Is this role suitable for freshers?

No, this is a senior-level role requiring 7–10 years of experience in regulatory affairs.

2. What type of products will I work on?

You will work on biologics, vaccines, and pharmaceutical products across global markets.

3. What submissions are involved in this role?

IND, NDA, BLA, MAA, DMF, IMPD, and lifecycle variations are key submissions handled.

4. Is this a remote job?

Yes, this role is fully remote within India.

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Summary

Category	Details
Company	Parexel
Vacancies	Regulatory Affairs Consultant
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, MSc, PhD
Experience	7–10 years