Job Description:

We are currently seeking a skilled and motivated CDSCO Regulatory Affairs Specialist to join our

team and ensure compliance with regulatory requirements for our Cosmetics/Medical Devices

portfolio, specifically focusing on the Sugam Portal and RA Department.

JOB REQUIREMENTS:

Basic knowledge for CDSCO Medical Device & Cosmetics;

·        Complete knowledge of the dossier preparation for Registration & Import License of Medical Device & Cosmetics into India.

·        Knowledge of the SUGAM Registration on CDSCO portal.

·        Knowledge of Cosmetic Import License under COS-2 & COS-4.

·        Knowledge of Cosmetic Manufacturing License under COS-8 & COS-9.

·        Knowledge of Medical Device Import License Form MD-15.

·        Knowledge of Medical Device Manufacturing Form MD-5 & Form MD-9.

·        Knowledge of guidelines regarding import of New Drugs, Medical Devices, Diagnostics into India.

·        Query replied for the deficiency letters obtained from CDSCO/DCGI.

·        Having track record on obtaining certificates for registration, import license, test license,

manufacturing license etc.

·        Submitted application form for registration, import license, personnel license for drugs, medical devices, diagnostic kits etc. on the behalf of so many pharmaceutical companies.

·        Regular follow up with the CDSCO for status of application.

Qualifications:

• Bachelors or Master's degree in Pharmacy, Life Sciences, or a related field.
• Minimum 1+ years of experience in regulatory affairs within the Cosmetics/Medical Devices industry, with a focus on CDSCO regulations and utilizing the Sugam Portal.
• Sound knowledge of CDSCO regulations and guidelines pertaining to Cosmetics/Medical Devices especially related to the Sugam Portal.
• Familiarity with the registration process for Cosmetics/Medical Devices in India, including dossier preparation and submission requirements via the Sugam Portal.
• Strong understanding of quality management systems and Good Manufacturing Practices (GMP) in the Cosmetics/Medical Devices industry.
• Excellent attention to detail and ability to interpret complex regulatory information.
• Effective communication and interpersonal skills to collaborate with internal and external

stakeholders.

• Proactive problem-solving abilities and ability to work independently with minimal supervision.
• Ability to prioritize tasks, meet deadlines, and adapt to changing regulatory requirements.

To apply for this position, please submit your resume and a cover letter outlining your relevant

experience and qualifications to hr@jrcompliance.com