Glenmark Pharmaceuticals is inviting applications for the position of Officer โ Plant Regulatory Affairs at its Pithampur Plant, Indore. This is an excellent opportunity for candidates with qualifications in B.Pharm, M.Pharm, Life Sciences, Chemistry, or related disciplines who are looking to build a career in Plant Regulatory Affairs, Global Regulatory Affairs, and Pharmaceutical Manufacturing Compliance.
The role offers exposure to global regulatory markets including USFDA, EMA, Canada, Australia, and Rest of World (ROW) while working closely with manufacturing, quality, and corporate regulatory teams. Candidates with strong knowledge of ICH guidelines, GMP, regulatory documentation, and pharmaceutical compliance will find this role highly rewarding.
Job Details
| Particular | Details |
|---|---|
| Position | Officer โ Plant Regulatory Affairs |
| Company | Glenmark Pharmaceuticals |
| Department | Global Regulatory Affairs |
| Job Location | Pithampur Plant, Indore, Madhya Pradesh |
| Employment Type | Full-Time |
| Industry | Pharmaceutical Manufacturing |
Key Responsibilities
The selected candidate will be responsible for:
- Review dossier documents for new product registrations, renewals, and post-approval variations.
- Support regulatory submissions for US, Europe, Canada, Australia, and ROW markets.
- Review change controls, deviations, incidents, and provide regulatory recommendations.
- Prepare and submit projected annual reports for the US market.
- Review and approve regulatory documents including:
- Batch Manufacturing Records (BMR)
- Process Validation Reports
- Hold Time Reports
- Stability Reports
- Nitrosamine Risk Assessment Reports
- Coordinate with R&D, Quality Assurance, Quality Control, Production, Purchase, and Corporate Regulatory teams.
- Support responses to regulatory authority queries.
- Monitor updates in global regulatory guidelines including ICH, USFDA, and EMA.
- Assist QA during regulatory inspections and audits.
- Ensure compliance with GMP, GCP, Site SOPs, and global regulatory standards.
Educational Qualification
Candidates with the following qualifications are eligible:
- B.Pharm
- M.Pharm
- Life Sciences
- Chemistry
- Related Science Discipline
Required Skills
Technical Skills
- Strong understanding of ICH Guidelines
- Knowledge of USFDA regulations
- Familiarity with EMA requirements
- Regulatory documentation expertise
- GMP and GCP compliance knowledge
Software & Systems
- SAP
- TrackWise
- OpenText
- MSB
- Microsoft Office
Soft Skills
- Analytical thinking
- Excellent written communication
- Attention to detail
- Project management
- Cross-functional coordination
- Negotiation skills
Why Join Glenmark?
Working with Glenmark offers:
- Exposure to international regulatory markets
- Career growth in Global Regulatory Affairs
- Opportunity to work on USFDA and EMA regulated products
- Cross-functional learning with manufacturing and quality teams
- Experience in regulatory inspections and global compliance
- Professional development in pharmaceutical regulatory affairs
Who Should Apply?
This opportunity is ideal for:
- B.Pharm graduates interested in Regulatory Affairs
- M.Pharm professionals seeking Plant Regulatory Affairs careers
- Life Sciences graduates with pharmaceutical manufacturing exposure
- Chemistry graduates interested in regulatory compliance
- Candidates with knowledge of ICH, USFDA, EMA, GMP, and documentation
How to Apply
