CDSCO Operations Manager

• Location: Motinagar, New Delhi

• Experience: 2-5 Year

• Employment Type: Full-Time

• Industry: Compliance & Certification Services

• Office Timing: 9:30AM to 6:30PM (No Overtime)

• Openings: 1

• Qualification: B.Pharm / M.Pharm / Pharm.D, B.Sc. / M.Sc. (Life Sciences, Biotechnology, Microbiology, Chemistry, or related field)

• Salary: As per interview and experience

Key Responsibilities:

• Manage end-to-end CDSCO regulatory projects for Medical Devices and Cosmetics.

• Handle CDSCO registrations, import licenses, manufacturing licenses, permissions, and other regulatory approvals.

• Review technical documentation and ensure compliance with applicable CDSCO regulations.

• Prepare, verify, and submit applications through the CDSCO SUGAM Portal

• Coordinate with clients to collect, review, and validate regulatory documents

• Follow up with clients regarding pending documents and approvals.

• Monitor project timelines and ensure timely completion of all assigned projects

• Liaise with CDSCO officials, testing laboratories, manufacturers, and other stakeholders whenever required.

• Stay updated with changes in CDSCO guidelines, Medical Devices Rules, Cosmetics Rules, and other applicable regulations.

• Work closely with the Business Development team to provide technical support during client discussions whenever required.

Required Skills:

• Strong knowledge of CDSCO regulations and regulatory procedures.

• Hands-on experience with the CDSCO SUGAM Portal.

• Excellent knowledge of Medical Devices Rules, 2017

• Good understanding of the Drugs & Cosmetics Act, 1940 and related Rules.

• Strong documentation review and regulatory compliance skills.

• Project management and team leadership abilities.

• Excellent communication and client coordination skills.

• Ability to manage multiple regulatory projects simultaneously.

• Proficiency in Microsoft Office (Excel, Word, Outlook).

Qualification:

• B.Pharm / M.Pharm / Pharm.D

• B.Sc. / M.Sc. (Life Sciences, Biotechnology, Microbiology or related field)

• Any equivalent qualification with relevant CDSCO regulatory experience

Experience:

• Minimum 2 years of hands-on experience in CDSCO Regulatory Affairs or Compliance Consultancy.

• Experience in handling Medical Device, Cosmetic, and Drug regulatory projects.

• Experience in managing client communication and regulatory documentation.

• Team handling experience will be an added advantage.

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