Company Introduction
Marksans Pharma Pvt Ltd is an India-based pharmaceutical manufacturer supplying finished dosage products to regulated and semi-regulated global markets.
Core Responsibilities
- Prepare and submit product licensing dossiers to Goa FDA and CDSCO using statutory forms, annexures, and supporting technical files.
- Compile site change applications by reviewing master formula records, layout drawings, and equipment qualification documents.
- Draft regulatory responses by referencing deficiency letters, review notes, and official inspection observations.
- Maintain approval trackers by updating product registration databases and license validity registers.
- Upload submissions and follow-ups on SUGAM and NSWS portals with supporting PDFs and scanned certificates.
- Review regulatory amendments and circulate notification summaries using controlled document templates.
Skills & Technical Exposure
- SUGAM online submission portal.
- NSWS regulatory approval system.
- Goa FDA and CDSCO application formats.
- Product license dossiers and site master files.
- Regulatory database trackers.
- Deficiency letter response documentation.
Experience Context
- Work environment includes pharmaceutical manufacturing units and corporate regulatory offices supporting licensed facilities.
- Role exposure covers multiple marketed products, site approvals, and post-approval change filings.
- Without regulatory submissions and approvals, product manufacturing and market supply halt.
How to Apply
muskan.shaikh@marksanspharma.com