Genpact Hiring Regulatory Affairs Specialist Job in Mumbai for CMC documentation and CTD submissions. Apply now for pharmaceutical regulatory career opportunity.
Job Overview
Genpact is currently inviting applications from qualified professionals for the position of Regulatory Affairs Specialist / Assistant Manager – Regulatory Affairs (CMC & Labelling) in Mumbai. This role offers an excellent opportunity for candidates with experience in regulatory documentation, CMC submissions, and pharmaceutical dossier preparation.
Professionals joining this position will contribute to regulatory submission activities for consumer healthcare and pharmaceutical products while ensuring compliance with global regulatory requirements. The role involves preparing technical documentation, supporting regulatory approvals, and working closely with cross-functional teams to ensure timely submission of dossiers. Genpact Hiring Regulatory Affairs Specialist Job
Company Overview
Genpact is a global professional services and business transformation company that delivers digital innovation and operational excellence to organizations across industries. Established as a business unit of General Electric and later becoming an independent company, Genpact now serves clients worldwide by combining domain expertise, advanced analytics, artificial intelligence, and digital technology.
The company supports pharmaceutical, healthcare, life sciences, and consumer product organizations by providing regulatory services, compliance support, and process transformation solutions. With a strong focus on innovation and operational efficiency, Genpact helps organizations streamline complex processes such as regulatory submissions, quality documentation, and product lifecycle management.
By joining Genpact, professionals gain the opportunity to work on global regulatory projects while collaborating with leading pharmaceutical companies and healthcare organizations. Genpact Hiring Regulatory Affairs Specialist Job
Job Location & Employment Type
Company: Genpact
Position: Regulatory Affairs Specialist / Assistant Manager – Regulatory Affairs
Department: Regulatory Affairs – CMC & Labelling
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Work Mode: On-site
Open Positions / Department Details
The role is part of the Regulatory Affairs team responsible for CMC (Chemistry, Manufacturing and Controls) and labelling documentation. The selected candidate will support global regulatory submission processes for consumer healthcare products.
Professionals working in this department collaborate with pharmaceutical clients to ensure accurate documentation, regulatory compliance, and timely submission of dossiers according to international regulatory guidelines. Genpact Hiring Regulatory Affairs Specialist Job
Key Roles & Responsibilities
Candidates selected for this position will be responsible for managing multiple regulatory activities related to pharmaceutical product registration and compliance. Genpact Hiring Regulatory Affairs Specialist Job
Regulatory Submission Management
- Support preparation and submission of regulatory dossiers for product registrations.
- Assist with both pre-approval and post-approval regulatory submissions.
- Ensure documentation aligns with international regulatory requirements and submission timelines.
CMC Documentation Preparation
- Prepare and author Chemistry, Manufacturing and Controls (CMC) documentation required for regulatory filings.
- Develop technical regulatory documents supporting product approval.
- Contribute to the preparation of Quality Overall Summary (QOS) sections within regulatory dossiers.
CTD Dossier Compilation
- Compile and organize documentation following the Common Technical Document (CTD) format.
- Prepare Module 3 sections of the CTD for regulatory submissions.
- Ensure the accuracy and completeness of technical data used in dossiers.
Data Review & Compliance Assessment
- Review manufacturing process documentation and ensure alignment with regulatory expectations.
- Evaluate analytical data, validation reports, and stability data for regulatory submissions.
- Support the evaluation of quality documentation during project renewals or regulatory updates.
Client & Regulatory Coordination
- Manage regulatory requirements for multiple client projects simultaneously.
- Coordinate with internal and external stakeholders to ensure submission readiness.
- Provide support to ensure regulatory documentation meets required quality standards.
Regulatory Documentation Management
- Maintain organized regulatory records and documentation.
- Ensure regulatory files are updated and compliant with applicable guidelines.
- Support internal teams in maintaining consistent regulatory processes.
Eligibility Criteria
Education
Applicants should possess one of the following qualifications:
- B.Pharm (Bachelor of Pharmacy)
- M.Pharm (Master of Pharmacy)
- B.Sc or M.Sc in Life Sciences
- Any equivalent qualification in pharmaceutical sciences or related life science disciplines.
Experience
Candidates applying for this role should have:
- Experience in Regulatory Affairs, CMC documentation, or pharmaceutical dossier preparation.
- Exposure to regulatory submissions and pharmaceutical documentation processes.
- Experience working in pharmaceutical companies, regulatory consulting organizations, or service providers supporting regulatory projects.
Genpact Hiring Regulatory Affairs Specialist Job
Skills Required
Candidates must demonstrate strong technical and professional capabilities relevant to regulatory affairs.
Regulatory Knowledge
- Understanding of regulatory submission processes.
- Familiarity with Common Technical Document (CTD) structure and submission requirements.
- Knowledge of global regulatory guidelines related to pharmaceutical products.
CMC Documentation Skills
- Experience preparing CMC documentation for regulatory filings.
- Ability to review manufacturing, validation, analytical, and stability documentation.
Technical Documentation
- Strong documentation skills with attention to regulatory compliance.
- Ability to prepare detailed technical regulatory reports.
Analytical & Organizational Skills
- Ability to manage multiple regulatory projects simultaneously.
- Strong analytical approach to evaluating technical documentation.
Communication & Collaboration
- Effective written and verbal communication skills.
- Ability to collaborate with internal teams and external clients.
- Capability to coordinate regulatory activities across multiple stakeholders.
Salary & Benefits
Estimated salary for this position is ₹8,00,000 – ₹18,00,000 per year, depending on experience, qualifications, and industry benchmarks.
Additional benefits may include professional development opportunities, performance incentives, and other employee benefits as per company policies.
Selection Process
Candidates applying for the Regulatory Affairs Specialist role may undergo the following recruitment stages:
- Online application submission
- Resume screening by the recruitment team
- Technical interview focused on regulatory affairs knowledge
- HR interview round
- Final selection and job offer
The exact hiring process may vary depending on company requirements.
How to Apply
Interested candidates who meet the eligibility requirements can apply for this role through the official Genpact career portal using the online application process.
Applicants are advised to ensure that their resume highlights relevant experience in regulatory affairs, CMC documentation, and CTD dossier preparation before submitting their application. Genpact Hiring Regulatory Affairs Specialist Job
Important Dates
The final application deadline has not been specified, so candidates are encouraged to apply at the earliest opportunity. Genpact Hiring Regulatory Affairs Specialist Job
Why Apply for This Pharma Job?
The Regulatory Affairs Specialist role at Genpact offers strong career growth opportunities for professionals interested in regulatory documentation and pharmaceutical compliance. Genpact Hiring Regulatory Affairs Specialist Job
Benefits of this opportunity include:
- Exposure to global regulatory submission projects
- Opportunity to work with international pharmaceutical and healthcare clients
- Experience with advanced digital solutions used in regulatory processes
- Career development opportunities through training and mentorship programs
- A collaborative workplace focused on innovation and professional growth
For candidates aiming to strengthen their expertise in regulatory affairs, CMC documentation, and global submission processes, this role provides valuable industry experience. Genpact Hiring Regulatory Affairs Specialist Job
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare career opportunities for job seekers. We are not affiliated with Genpact or any recruitment agency mentioned in this post. We do not charge any fees for job applications. Candidates should always apply through the official company website and verify details before submitting personal information. Genpact Hiring Regulatory Affairs Specialist Job
Final Call-to-Action
If you have experience in regulatory affairs, CMC documentation, or CTD dossier preparation and are looking for a new opportunity in Mumbai, this role at Genpact could be a strong step forward in your career. Qualified candidates should apply through the official application portal and ensure their resume clearly highlights relevant regulatory experience. Genpact Hiring Regulatory Affairs Specialist Job
