Drug Regulatory Affairs

Requirement of Regulatory Affair- Manager

Industry - Pharma/Healthcare

Address

-16, Strand Road, Diamond Heritage Building,7th floor, Room-705 , Kolkata-700001

Job Role

Regulatory Affairs-Manager/Asst. Manager/Sr. Executive

Salary

Negotiable

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

• Leave encashment
• Provident Fund

Work Location

In person