Regulatory Affairs Specialist

Job Title:

Manager – Regulatory and Compliance

Location:

Indore

Department:
Regulatory Affairs / Compliance

Role Overview :

We are seeking a highly skilled Manager of Regulatory and Compliance to lead and oversee the compliance function for Kimirica’s 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 India’s CDSCO, US FDA, EU Cosmetics Regulation, BIS, and other relevant authorities.
- Manage product registrations, certifications, and approval processes in diverse international markets.
- Continuously 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 and 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.