Kaisha Life sciences Private Limited is a pharmaceutical company, a part of the Dadachanji Group of Companies. It's known for its commitment to producing safe, high-quality, and effective medications. The company also provides contract research and development (R&D) services to other pharmaceutical companies.
Post : Deputy Manager - Regulatory Affairs
Educational Qualification : Bachelor’s/ master’s in pharmacy
Professional Experience
Having 10-14 years in Regulatory Affairs.
Major Job Responsibilities :
• Develop and execute regulatory strategies for product registration; manage submissions, licenses, and renewals with health authorities (FDA, EMA, etc.).
• Dossier preparation for Regulatory submissions regarding CTD & eCTD in LATAM. Africa, MENA, South East Asia, CIS, EU, US.
• Advise R&D. clinical, and manufacturing teams on compliance requirements to reduce regulatory review cycle.
• Review and approve technical documents, labelling, advertising, and marketing materials for regulatory compliance.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Train staff in regulatory policies or procedures.
• Team player with good leadership qualities, good social skills and ability to work in teams.
• Negotiate solutions in the best interests of the company. Assist to investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives.
• A thorough understanding of ICH GCP, Regulatory requirements worldwide (particularly FDA and EMA) plus a knowledge of the EU directives 2001/20/EC, 2005/28/EC and 2003/94/EC and UK Statutory Instruments SI2004:1031, SE2006:1528 and subsequent amendments.
Interested candidates can share their resume on the Email ID below
Email ID : hrd@kaishalifesciences.com
Last Date : 15th March 2026
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