Genpact is hiring for the position of Specialist โ Regulatory Affairs โ Operations. This is an excellent opportunity for experienced professionals with expertise in Regulatory Affairs, regulatory submissions, pharmaceutical compliance, eCTD, CTD, ICH guidelines, and regulatory operations.
The Genpact Regulatory Affairs Specialist job is open for candidates with 3โ7 years of experience. The position involves researching regulations, supporting compliance policies, conducting audits and risk assessments, monitoring regulatory compliance, and coordinating with legal and regulatory stakeholders.
Job Details
| Particulars | Details |
|---|---|
| Company | Genpact |
| Job Role | Specialist โ Regulatory Affairs โ Operations |
| Department | Legal & Regulatory |
| Employment Type | Full-Time, Permanent |
| Experience | 3โ7 Years |
| Openings | 4 |
| Location | Nashik, Navi Mumbai, Nagpur |
| Industry | BPM / BPO |
| Salary | โน6 โ โน12 LPA (Estimated) |
About the Role
The Specialist โ Regulatory Affairs โ Operations will work in a highly regulated and process-driven environment. The role requires a strong understanding of pharmaceutical regulatory affairs and compliance processes.
The selected candidate will support regulatory operations by researching applicable regulations, developing compliance procedures, monitoring compliance activities, conducting internal audits, and responding to regulatory requirements.
Candidates with knowledge of Regulatory Submissions, Drug Regulatory Affairs, eCTD, CTD, ICH guidelines, XEVMPD, regulatory reports, document review, and pharmaceutical regulations may find this opportunity highly relevant.
Key Responsibilities
As a Regulatory Affairs Specialist at Genpact, your responsibilities may include:
- Researching and staying updated on industry regulations.
- Monitoring changes in pharmaceutical and healthcare regulations.
- Developing and implementing compliance policies and procedures.
- Supporting regulatory compliance activities.
- Conducting internal audits.
- Performing risk assessments.
- Identifying and reporting compliance issues.
- Providing guidance on regulatory and compliance matters.
- Supporting training activities related to compliance requirements.
- Monitoring and reporting compliance issues to management.
- Collaborating with legal and other departments.
- Addressing regulatory and compliance concerns.
- Responding to inquiries from regulatory authorities.
- Supporting regulatory documentation and submissions.
- Working within established regulatory processes and quality standards.
Qualifications Required
The job description mentions the following educational qualifications:
Eligible Degrees
Bachelor’s in Health Administration, Healthcare, Pharmacy, or B.Sc. Chemistry OR Master’s in Public Health or Regulatory Affairs.
The education section also specifically mentions:
- B.Sc. in Chemistry
- B.Pharm in Pharmaceutical Analysis and Quality Assurance
Qualification Summary
Bachelor’s Degree in Health Administration, Healthcare, Pharmacy, or Chemistry OR Master’s Degree in Public Health or Regulatory Affairs.
Experience Required
3โ7 Years of Experience
The role is targeted toward experienced professionals with relevant exposure to:
- Regulatory Affairs
- Drug Regulatory Affairs
- Regulatory Operations
- Regulatory Submissions
- Pharmaceutical Compliance
- Document Review
- Regulatory Documentation
Key Skills Required
Candidates applying for this Genpact Regulatory Affairs job may benefit from knowledge of:
- Regulatory Affairs
- Drug Regulatory Affairs
- Regulatory Operations
- Regulatory Submissions
- Pharmaceutical Regulations
- Regulatory Compliance
- eCTD
- CTD
- ICH Guidelines
- XEVMPD
- Regulatory Reports
- Document Review
- Pharmaceutical Industry
- Compliance Management
- Internal Audits
- Risk Assessment
- DocuBridge
- IDM
- Liquent
Who Should Apply?
This Regulatory Affairs Specialist job may be suitable for professionals with 3โ7 years of experience in:
- Pharmaceutical Regulatory Affairs
- Regulatory Operations
- Regulatory Publishing
- Drug Regulatory Affairs
- eCTD Publishing
- Regulatory Submissions
- CTD/eCTD Documentation
- Regulatory Compliance
- Pharmaceutical Documentation
- Document Management
Candidates with experience in regulatory publishing tools and systems such as DocuBridge, IDM, and Liquent may have relevant skills for this position.
Why Join Genpact?
Genpact offers opportunities to work in a technology-driven and global business environment.
According to the job description, potential benefits of joining include:
- Exposure to AI, automation, and digital innovation.
- Opportunities to work on global business challenges.
- Hands-on experience and professional development.
- Mentorship and continuous learning opportunities.
- Collaboration with global teams.
- A values-driven work environment.
- Career development opportunities.
- An inclusive workplace focused on integrity and innovation.
Specific employee benefits may vary based on location, eligibility, and company policies.
Salary for Regulatory Affairs Specialist at Genpact
The salary for this role has not been officially disclosed.
Based on the role level, required experience, and Regulatory Affairs Operations responsibilities, the estimated salary range may be:
โน6 LPA โ โน12 LPA (Estimated)
Actual compensation may vary based on:
- Years of experience.
- Regulatory Affairs expertise.
- Experience with eCTD and CTD submissions.
- Regulatory publishing experience.
- Technical skills.
- Location.
- Internal compensation policies.
Disclaimer: The salary range above is an editorial estimate and is not officially disclosed by Genpact.
Job Locations
This Genpact Regulatory Affairs Specialist opportunity lists the following locations:
- Nashik, Maharashtra
- Navi Mumbai, Maharashtra
- Nagpur, Maharashtra
Candidates should verify the preferred work location and final work arrangement during the recruitment process.
How to Apply
