If you’re looking to build a strong career in Regulatory Affairs (API), this opportunity at Enaltec in Ambernath, Mumbai is highly relevant. This role is ideal for candidates with 0โ3 years of experience who have foundational exposure to Drug Master Files (DMF) and CTD/eCTD submissions.
With increasing global compliance requirements in the pharmaceutical sector, professionals skilled in API regulatory affairs, DMF compilation, and ICH guidelines are in high demand. This role offers hands-on exposure to regulatory documentation, submissions, and cross-functional collaboration.
Job Overview
- Role: Officer / Sr. Officer โ Regulatory Affairs (API)
- Company: Enaltec
- Location: Ambernath, Mumbai, Maharashtra, India
- Experience: 0โ3 years
- Employment Type: Full-Time, Permanent
- Industry: Pharmaceutical & Life Sciences
Key Responsibilities
- Prepare and compile Drug Master Files (DMF) for API products
- Handle CTD/eCTD format submissions for regulatory filings
- Coordinate with R&D, QA, QC, and Production teams for data collection
- Respond to regulatory authority and customer queries
- Maintain and update regulatory documentation and databases
- Review analytical, manufacturing, and quality documents
- Ensure compliance with ICH and global regulatory guidelines
- Track submission timelines and maintain accurate records
Required Qualifications
- Educational Qualification:
- M.Pharm / M.Sc / MS in Life Sciences or related field
- Skills & Knowledge:
- Understanding of API Regulatory Affairs
- Knowledge of DMF, CTD, and eCTD structure
- Familiarity with ICH guidelines and regulatory compliance
- Strong documentation and coordination skills
- Ability to manage multiple regulatory tasks efficiently
Preferred Candidate Profile
- Experience in DMF preparation and submission
- Exposure to regulatory audits and compliance processes
- Detail-oriented with strong analytical thinking
- Willingness to learn and grow in regulatory affairs domain
Salary & Benefits
- Estimated Salary Range: โน2.5 LPA โ โน5.5 LPA
- Opportunity to work in API regulatory affairs domain
- Exposure to global regulatory submissions
- Career growth in a compliance-driven pharma environment
- Collaborative work culture with cross-functional teams
Why This Role Matters
Regulatory Affairs professionals play a critical role in ensuring that pharmaceutical products meet global safety, quality, and compliance standards. With increasing scrutiny from regulatory agencies, expertise in DMF and CTD submissions is becoming a core competency in the pharma industry.
This position at Enaltec provides a strong foundation for a long-term career in API regulatory affairs, dossier management, and international submissions.
How to Apply
