Regulatory Affairs Executive

Sunrise Remedies Pvt. Ltd.

Website: sunriseremedies.in
Job details:

Company Description

Sunrise Remedies Pvt. Ltd. is an ISO 9001:2015 Certified Company specializing in the manufacturing of high-quality pharmaceutical products. With a strong emphasis on excellence, the company operates a WHO and GMP Certified Manufacturing Plant. Sunrise Remedies is committed to delivering top-tier pharmaceutical solutions designed to meet diverse healthcare needs.

Role Description

• Prepare and compile regulatory dossiers (CTD/ACTD format) for product registrations in international markets.
• Coordinate with manufacturers to obtain regulatory documents such as COA, GMP, Stability Data, FSC/CPP, and product permissions.
• Manage product registration submissions, renewals, and variations with regulatory authorities.
• Reviewing and compiling regulatory documents
• Managing document requisition and regulatory compliance requirements
• Supporting product registration in global markets
• Coordinating with internal departments for regulatory submissions
• Ensuring adherence to country-specific regulatory guidelines

Qualifications

• Experience: 01 To 02 Year in Regulatory Affairs
• Qualification: B.Pharm | M.Pharm
• Department: Regulatory Affairs
• Location: Santej Ahmedabad.
• CTC: Up to 2.40 Lakh LPA 
• LOCAL CANDIDATE PREFFERED

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