Genpact Hiring Regulatory Affairs Specialists

Genpact Hiring Regulatory Affairs Specialists in Mumbai – B.Pharm & MSc Graduates Eligible

Genpact has announced new hiring for the position of Regulatory Affairs Specialist / Assistant Manager – Regulatory Affairs (CMC & Labelling) in its pharmaceutical regulatory services division. The full‑time on‑site role is based in Mumbai, Maharashtra, and is open to candidates with life‑science and pharmacy backgrounds who want to build careers in global regulatory affairs, CMC documentation, and pharmaceutical compliance.

The opening reflects the growing demand for regulatory professionals who can support global pharmaceutical companies with drug registration, dossier preparation, and regulatory submissions. Candidates with B.Pharm, M.Pharm, B.Sc, or M.Sc qualifications will have the opportunity to work on global regulatory projects, including preparation of CTD documentation, quality summaries, and regulatory compliance activities.

For professionals interested in regulatory strategy, pharmaceutical quality documentation, and international drug approval processes, this role offers exposure to large global pharmaceutical clients and modern regulatory technology platforms.

Company Overview

Genpact is a global professional services and digital transformation company listed on the New York Stock Exchange (NYSE: G). The organization helps leading enterprises across industries improve business operations through technology, analytics, automation, and artificial intelligence.

With a workforce of more than 140,000 professionals across multiple countries, Genpact delivers solutions for industries including healthcare, life sciences, banking, manufacturing, insurance, and consumer services. The company combines domain expertise with advanced digital tools to help global organizations transform their operations.

Within the life sciences and healthcare sector, Genpact supports pharmaceutical and biotechnology companies with regulatory operations, pharmacovigilance support, clinical services, and compliance solutions. These services help pharmaceutical companies maintain global regulatory standards and accelerate the launch of new medicines.

Genpact also promotes a culture focused on innovation, learning, and professional development. Employees work with advanced digital technologies and AI‑driven platforms that help improve regulatory workflows and operational efficiency for global pharmaceutical clients.

Job Role & Responsibilities

The Regulatory Affairs Specialist / Assistant Manager – Regulatory Affairs (CMC & Labelling) will support regulatory documentation and submission activities for pharmaceutical and consumer healthcare products.

The role focuses heavily on Chemistry, Manufacturing and Controls (CMC) documentation and regulatory dossier preparation used for global product registrations.

Key responsibilities include:

• Handling regulatory requirements for new product registrations and regulatory submissions
• Supporting pre‑approval and post‑approval regulatory submissions for pharmaceutical products
• Compiling and submitting technical documentation for consumer healthcare products within defined timelines
• Authoring Quality Overall Summaries (QOS) and preparing documentation for Module 3 CTD sections
• Writing CMC quality documentation for regulatory dossiers using available raw data
• Reviewing existing regulatory quality documentation and identifying required updates during project renewals
• Assessing manufacturing, analytical, validation, and stability documentation
• Ensuring regulatory submissions comply with international regulatory guidelines
• Supporting regulatory compliance initiatives for global pharmaceutical clients

This role plays a critical part in supporting the regulatory approval pathway for pharmaceutical products by ensuring documentation meets international regulatory standards.

Eligibility / Qualifications

Candidates applying for this regulatory affairs position should have strong pharmaceutical knowledge and an understanding of regulatory submission processes.

Educational Qualification

Candidates should hold a degree in life sciences or pharmaceutical sciences such as:

B.Pharm, M.Pharm, B.Sc Life Sciences, B.Sc Biotechnology, B.Sc Microbiology, B.Sc Biochemistry, M.Sc Biotechnology, M.Sc Microbiology, M.Sc Biochemistry, M.Sc Life Sciences.

Required Skills and Experience

Candidates are expected to demonstrate the following:

• Experience or knowledge in regulatory affairs, CMC documentation, and regulatory compliance
• Understanding of CTD documentation structure and regulatory submission requirements
• Experience preparing Quality Overall Summaries (QOS) and Module 3 regulatory documentation
• Knowledge of manufacturing, analytical, validation, and stability documentation
• Strong documentation and regulatory writing skills
• Ability to work with cross‑functional teams across regulatory, quality, and manufacturing domains
• Strong analytical and organizational skills

Candidates who have experience working in pharmaceutical regulatory operations or regulatory consulting environments may have an advantage during the hiring process.

Location & Salary

Location: Mumbai, Maharashtra, India

Work Mode: On‑site

Application Process

Interested candidates can apply through the official job listing using the link below:

Apply Online:

https://www.linkedin.com/jobs/view/4383494678

Applicants may be contacted by the recruitment team for further evaluation, interview scheduling, and verification of qualifications.

Candidates are advised to keep their updated resume and regulatory experience details ready while applying for the role.

Frequently Asked Questions (FAQs)

Who can apply for the Genpact Regulatory Affairs role?

Candidates with B.Pharm, M.Pharm, B.Sc, or M.Sc life science qualifications with regulatory documentation knowledge can apply for this role.

What is the main focus of this regulatory affairs role?

The role focuses on CMC regulatory documentation, CTD dossier preparation, and Quality Overall Summary writing for pharmaceutical product submissions.

Is regulatory affairs experience required?

Experience in regulatory operations, CMC documentation, or pharmaceutical regulatory writing is generally preferred for this position.

Where is the job located?

The role is based in Mumbai, Maharashtra, and requires working on‑site with Genpact’s regulatory operations team.

What career growth opportunities exist in regulatory affairs?

Professionals in regulatory affairs can grow into roles such as Regulatory Affairs Manager, Global Regulatory Lead, Regulatory Strategy Consultant, or CMC Specialist.

Summary

Company	Genpact
Vacancies	Regulatory Affairs Specialist / Assistant Manager – Regulatory Affairs (CMC & Labelling)
Required Education	B.Pharm, M.Pharm, B.Sc Biotechnology, B.Sc Microbiology, B.Sc Biochemistry, B.Sc Life Sciences, M.Sc Biotechnology, M.Sc Microbiology, M.Sc Biochemistry
Experience	Regulatory Affairs / CMC Documentation / Pharmaceutical Regulatory Operations

Tagged as: Pharma Jobs in Mumbai