Ligasure Healthcare

Requirement of Regulatory Affair- Manager Industry - Pharma/Healthcare(Only for Male) Address:-Diamond Heritage Building,BBD Bag, Kol-700001 Job Role: Regulatory Affairs-Manager/Asst.Manager Salary: Negotiable (No PF & ESI,only P-Tax deduction) Qualification: - · Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or related discipline. Key Responsibilities: · Develop and implement regulatory strategies for assigned products in ROW markets. · Provide regulatory guidance during product development, lifecycle management, and market expansion projects. · Interpret international regulations and communicate implications to internal stakeholders. · Prepare, review, and submit dossiers (CTD/eCTD or country-specific formats) for new registrations, renewals, and variations. · Liaise with local affiliates, agents, or distributors for country-specific requirements and submissions. · Track and manage submission timelines and ensure timely approvals. · Monitor changes in regulatory requirements across ROW markets and assess impact on existing and future products. · Ensure regulatory compliance of product labels, artwork, and promotional materials. · Support audits and inspections related to regulatory affairs. · Work closely with R&D, QA, Manufacturing, Supply Chain, and Commercial teams to support regulatory needs. · Coordinate with external consultants, local agents, and distributors for regulatory filings and follow-ups. Who are interested, please share their resume - mrinmay.d@ligasurehealthcare.com Job Types: Full-time, Permanent Pay: ₹25,000.00 - ₹60,000.00 per month Benefits: Cell phone reimbursement Leave encashment Work Location: In person