CDSCO Operations Manager

SS Global Services; New Delhi; On-site; INR 600,000 - 1,200,000; Full time

Job summary

SS Global Services in New Delhi is seeking a Regulatory Affairs professional to manage end-to-end CDSCO regulatory projects for Medical Devices and Cosmetics. You will handle registrations, licenses, and other approvals, review technical docs, and submit applications via the CDSCO SUGAM Portal.

The ideal candidate has 2–5 years of hands-on CDSCO regulatory experience, with strong knowledge of relevant acts and rules, and excellent client coordination skills.

Qualifications

• Must-have knowledge of CDSCO regulations and regulatory procedures.
• Hands-on experience with the CDSCO SUGAM Portal.
• Strong familiarity with Medical Devices Rules, 2017 and Drugs & Cosmetics Act, 1940.

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.

Skills

CDSCO regulations

CDSCO SUGAM Portal

Medical Devices Rules, 2017

Drugs & Cosmetics Act, 1940

regulatory documentation

regulatory compliance

project management

team leadership

client coordination

multi-project management

MS Office

Education

B.Pharm / M.Pharm / Pharm.D

B.Sc./M.Sc. Life Sciences/Biotechnology/Microbiology/Chemistry

Equivalent CDSCO-regulatory experience

Tools

MS Office

Job description

• 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.