Remote Regulatory affairs Associate Vacancies – CMC Parexel

Parexel Hiring Regulatory Affairs Associate – CMC Regulatory Job | Bengaluru / Remote India

Parexel is currently hiring for the position of Regulatory Affairs Associate as part of its global consulting and regulatory services team. The role is based in Bengaluru, India, with additional flexibility to work remotely within India. This opportunity is designed for professionals with 2–5 years of experience in Regulatory Affairs – CMC (Chemistry, Manufacturing and Controls) who want to work on global regulatory submissions and product lifecycle management for pharmaceutical and biotechnology companies.

The Regulatory Affairs Associate will support regulatory strategy development, regulatory documentation review, dossier preparation, and submission management for global health authorities. Professionals in this role work closely with cross‑functional teams and clients to ensure that pharmaceutical products meet regulatory requirements and successfully reach global markets.

For candidates looking to build long‑term careers in regulatory affairs, pharmaceutical regulatory strategy, CMC documentation, and global drug approvals, this role offers exposure to international regulatory frameworks including EU submissions and CTD documentation systems.

Company Overview

Parexel is a globally recognized clinical research organization (CRO) and consulting partner for pharmaceutical, biotechnology, and medical device companies. The company supports clients across the entire drug development lifecycle including clinical trials, regulatory consulting, pharmacovigilance, and medical communications.

With decades of experience in global regulatory strategy and market access support, Parexel helps healthcare companies navigate complex regulatory environments across major markets such as the United States, Europe, and Asia. The organization works with a diverse portfolio of therapeutic areas and product types including small molecules, biologics, and advanced therapies.

Parexel’s consulting teams collaborate with regulatory authorities worldwide and help companies prepare submission dossiers, manage regulatory lifecycle changes, and accelerate product approvals. Employees benefit from global exposure to regulatory frameworks, cross‑functional collaboration, and continuous professional development.

Working with Parexel provides professionals an opportunity to develop expertise in international regulatory affairs and contribute to the successful approval of innovative medicines and healthcare products.

Job Role and Responsibilities

The Regulatory Affairs Associate will support regulatory submission planning and regulatory documentation management for pharmaceutical products across different global markets. The role requires strong knowledge of CMC regulatory requirements and submission processes.

Key responsibilities include:

• Understanding global regulatory frameworks and regional regulatory trends for pharmaceutical product submissions
• Supporting regulatory strategy and submission planning for assigned projects
• Providing regulatory input on Chemistry, Manufacturing and Controls (CMC) documentation
• Reviewing regulatory documents and ensuring compliance with health authority requirements
• Developing and maintaining regulatory submission delivery plans and content plans
• Coordinating with cross‑functional teams involved in product development and regulatory activities
• Authoring and updating dossier sections based on modifications to approved Marketing Authorization Applications (MAA)
• Performing regulatory change evaluations according to country‑specific regulatory guidelines
• Supporting lifecycle management activities for pharmaceutical products in European markets
• Reviewing regulatory dossiers before submission to ensure completeness and accuracy
• Submitting regulatory dossiers to health authorities and supporting approval negotiations
• Collaborating with regulatory, medical, marketing, and market access teams to assess impact of product changes
• Providing regular updates on regulatory submission status to stakeholders

This role is critical in ensuring pharmaceutical products meet regulatory requirements and are successfully approved in international markets.

Eligibility and Qualifications

Candidates applying for this regulatory affairs job should meet the following criteria.

Required Education

Bachelor’s or Master’s degree in life sciences, pharmacy, or related healthcare disciplines.

Relevant courses include:

Pharmacy, Pharmacology, Biotechnology, Biochemistry, Microbiology, Life Sciences, Biomedical Sciences, Clinical Research, Molecular Biology, Pharmaceutical Sciences

Experience

• 2–5 years of experience in Regulatory Affairs – CMC within pharmaceutical, biotechnology, or CRO environments
• Experience in regulatory submissions and dossier preparation

Required Skills

• Knowledge of global regulatory frameworks and submission procedures
• Strong understanding of Chemistry, Manufacturing and Controls (CMC) documentation
• Experience with Common Technical Document (CTD) guidelines
• Knowledge of regulatory procedures for marketing authorization applications
• Strong document review and regulatory writing skills
• Ability to collaborate with cross‑functional pharmaceutical development teams
• Strong communication and stakeholder management abilities

Preferred Knowledge

• Experience with regulatory lifecycle management activities in EU markets
• Exposure to health authority interactions and regulatory submission negotiations

Location and Salary

Primary Location: Bengaluru, India
Additional Work Option: Remote within India

The role may require collaboration with global teams and may involve working in EU shift hours depending on project requirements.

Salary details for this position have not been publicly disclosed and typically depend on candidate experience, regulatory expertise, and previous exposure to pharmaceutical regulatory submissions.

Application Process

Candidates interested in this regulatory affairs opportunity can apply through the official Parexel careers portal.

Apply here:

https://jobs.parexel.com/en/job/-/-/877/92409690064

Applicants are advised to apply only through the official company website to ensure authenticity and avoid recruitment scams.

Frequently Asked Questions

What does a Regulatory Affairs Associate do?

A Regulatory Affairs Associate prepares and manages regulatory documentation, supports submission strategies, and ensures pharmaceutical products comply with regulatory guidelines required for approval.

What qualifications are required for this role?

Candidates typically require a degree in pharmacy, biotechnology, pharmacology, or life sciences.

How much experience is required?

Parexel requires approximately 2–5 years of experience in Regulatory Affairs CMC for this position.

What regulatory systems or guidelines should candidates know?

Knowledge of CTD guidelines, marketing authorization applications (MAA), and regulatory procedures in EU markets is important.

How can I apply for this job?

Candidates can apply through the official Parexel careers website using the application link provided above.

Job Summary

Company	Parexel
Vacancies	Regulatory Affairs Associate
Required Education	Pharmacy, Pharmacology, Biotechnology, Biochemistry, Microbiology, Life Sciences, Biomedical Sciences, Clinical Research, Molecular Biology, Pharmaceutical Sciences
Experience	2–5 years Regulatory Affairs CMC experience

Tagged as: Pharma Jobs in Bangalore