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CDSCO Regulatory Affairs Specialist

CDSCO Regulatory Affairs Specialist

LifelancerDelhi, India
22 days ago
Job type
  • Quick Apply
Job description

Job Title : CDSCO Regulatory Affairs Specialist

Job Location : Delhi, India

Job Location Type : On-site

Job Contract Type : Full-time

Job Seniority Level : Executive

Skills :

CDSCO regulatory submissions, Pharmaceutical compliance, Dossier preparation, Regulatory change management, Product lifecycle management, EudraLex guidelines, Regulatory intelligence, Project management tools,

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

    Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

    For more details and to find similar roles, please check out the below Lifelancer link.

    https : / / lifelancer.com / jobs / view / f044b3aaa9f432d72d05a46b59c69796

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