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 - [email protected]

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹60,000.00 per month

Benefits

• Leave encashment
• Provident Fund

Work Location: In person