Regulatory Manager
2 days ago
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 -
Job Types: Full-time, Permanent
Pay: ₹25, ₹60,000.00 per month
Benefits:
- Cell phone reimbursement
- Leave encashment
Work Location: In person
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