Apply for Regulatory Affairs Officer API job at Enaltec Mumbai. Check eligibility, salary, experience, and application details for freshers and professionals.
Introduction
Are you planning to start or grow your career in API regulatory affairs? The Regulatory Affairs Officer API Job at Enaltec offers an excellent entry-level opportunity for candidates with up to 3 years of experience. This role provides hands-on exposure to Drug Master Files (DMF), CTD/eCTD submissions, and global regulatory compliance, making it ideal for freshers and early professionals in the pharma industry.
Job Overview
| Particulars | Details |
|---|---|
| Job Title | Officer / Sr. Officer – Regulatory Affairs (API) |
| Company Name | Enaltec |
| Location | Ambernath, Mumbai, Maharashtra |
| Employment Type | Full-time, Permanent |
| Department | Regulatory Affairs (API) |
| Experience Required | 0–3 Years |
| Education | M.Pharm / M.Sc / MS (Life Sciences) |
| Salary | ₹2.5 LPA – ₹5.5 LPA |
Company Overview
Enaltec is a well-known pharmaceutical company specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs). The organization focuses on regulatory compliance, quality manufacturing, and global market presence. Enaltec provides a strong platform for professionals to gain expertise in API regulatory submissions and international compliance standards.
Job Location & Employment Type
- Location: Ambernath, Mumbai, Maharashtra, India
- Work Mode: On-site
- Job Type: Full-time, Permanent
Candidates will work closely with internal teams and regulatory departments at the manufacturing facility.
Open Positions / Department Details
- Department: Regulatory Affairs (API)
- Role Focus:
- DMF preparation and submission
- CTD/eCTD documentation
- API regulatory compliance
Key Roles & Responsibilities
As a Regulatory Affairs Officer (API), your responsibilities will include:
- Preparing and compiling Drug Master Files (DMF) for API products
- Handling CTD and eCTD submissions for regulatory filings
- Coordinating with R&D, QA, QC, and Production teams for required data
- Responding to regulatory authority queries and client requirements
- Maintaining and updating regulatory documentation and databases
- Reviewing analytical, manufacturing, and quality-related documents
- Ensuring compliance with ICH guidelines and global standards
- Tracking submission timelines and maintaining accurate records
Eligibility Criteria
Education
- M.Pharm
- M.Sc / MS in Life Sciences
- Or related field
Experience
- 0–3 years of experience in regulatory affairs
- Freshers with relevant academic exposure may also apply
Skills Required
- Basic understanding of API regulatory affairs
- Knowledge of DMF, CTD, and eCTD formats
- Familiarity with ICH guidelines
- Strong documentation and coordination skills
- Ability to manage multiple tasks efficiently
- Good communication and analytical skills
Salary & Benefits
- Estimated Salary: ₹2.5 LPA – ₹5.5 LPA
- Exposure to API regulatory affairs and global submissions
- Opportunity to work on DMF and dossier preparation
- Career growth in regulatory compliance domain
- Learning environment with cross-functional collaboration
- Stable and growth-oriented pharma industry role
Selection Process
The recruitment process may include:
- Resume screening
- Technical interview (Regulatory Affairs basics)
- HR round
Candidates with knowledge of DMF and CTD submissions will have an advantage.
How to Apply
- Apply through the official application link provided in the job post
Important Dates
- Published On: April 3, 2026
- Last date not specified (Apply early)
Why Apply for This Job?
The Regulatory Affairs Officer API Job at Enaltec is an ideal starting point for candidates interested in regulatory affairs within the API sector. It offers practical exposure to global documentation standards, including DMF and CTD formats, which are essential for regulatory careers.
With increasing demand for regulatory professionals in the pharmaceutical industry, this role helps build a strong foundation for long-term growth in compliance, submissions, and international regulatory affairs.
FAQs
1. Who can apply for this job?
Candidates with M.Pharm, M.Sc, or MS in Life Sciences with 0–3 years of experience can apply.
2. Is this job suitable for freshers?
Yes, freshers with relevant academic knowledge in regulatory affairs may be considered.
3. What is the salary offered?
The salary ranges between ₹2.5 LPA to ₹5.5 LPA depending on experience.
4. What skills are required for this role?
Knowledge of DMF, CTD/eCTD, ICH guidelines, and documentation skills are important.
5. Where is the job located?
The job is based in Ambernath, Mumbai, and requires on-site work.
Conclusion
The Regulatory Affairs Officer API Job at Enaltec is a great opportunity for aspiring regulatory professionals. With exposure to real-time regulatory submissions and global standards, this role can significantly boost your career in the pharmaceutical industry. Interested candidates should apply as soon as possible.
Disclaimer
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