Regulatory Affairs Manager

2 weeks ago

Indore, India Kimirica Hunter International Full time

Job Title: Manager – Regulatory and Compliance Location: IndoreDepartment: Regulatory AffairsRole Overview:Kimirica Hunter International is seeking a highly skilled Manager – Regulatory and Compliance to lead and oversee the compliance function for our diverse product portfolio. The ideal candidate will bring extensive expertise in regulatory requirements across India, the US, Europe, and other international markets, with a strong focus on cosmetics and pharmaceutical industries.Key Responsibilities:Develop and lead regulatory and compliance strategies for all Kimirica products across multiple markets.Ensure strict adherence to global regulatory frameworks including CDSCO (India), US FDA, EU Cosmetics Regulation, BIS, and other relevant authorities.Manage product registrations, certifications, and approval processes in diverse international markets.Monitor and interpret evolving regulatory trends, standards, and guidelines.Collaborate closely with R&D, Legal, Production, and Marketing teams to ensure compliance throughout product development, launch, and post-market surveillance.Prepare and maintain comprehensive regulatory documentation, manage submissions, and coordinate internal and external audits.Serve as the primary liaison with regulatory agencies to facilitate timely approvals and certifications.Lead risk assessments, internal compliance audits, and oversee corrective actions to mitigate regulatory risks.Mentor and guide team members on regulatory best practices and compliance policies.Required Skills & Qualifications:Minimum 8 years of experience in regulatory affairs within the cosmetics, pharmaceutical, or FMCG sectors.In-depth knowledge of global regulatory frameworks including FDA (US), EU Cosmetics Regulation, Indian regulations, and BIS.Proven track record of managing product registrations, compliance audits, labelling requirements, and testing protocols.Strong leadership capabilities with excellent communication, negotiation, and interpersonal skills.Proficiency in regulatory management software and MS Office Suite.Ability to work cross-functionally and manage multiple projects simultaneously.Why Join Kimirica?Opportunity to lead regulatory strategy for innovative products impacting global markets.Collaborative and dynamic work environment.Career growth and development in a fast-growing industry.How to Apply:Interested candidates can share their CVs at or apply through our careers page: Apply Here .

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