Regulatory & Licensing Manager (Pharmaceuticals)

4 days ago

Bandra Mumbai Maharashtra, India Janis Care Pvt Ltd Full time

Job Description: Regulatory & Licensing Executive (Pharmaceuticals)

Company: Janis Care Pvt. Ltd.

Location: Bandra Mumbai

Experience Required: 5–7 Years

Qualification: B.Pharm (Mandatory)

Department: Regulatory & Compliance

Reporting To: Regulatory Manager / Operations Head

Role Overview:

Janis Care Pvt. Ltd. is seeking a competent Regulatory & Licensing Executive with 5–7 years of hands-on experience in dealing with Drug Inspectors, regulatory authorities, and pharmaceutical licensing requirements. The ideal candidate must possess strong knowledge of regulatory frameworks, including NDPS Act, Schedule X, and other statutory norms applicable in the pharmaceutical sector.

This role requires someone who can independently manage compliance documentation, coordinate licensing renewals/approvals, maintain statutory records, and ensure adherence to all regulatory requirements of the organisation.

Key Responsibilities:Regulatory & Licensing Management

  • Manage all documentation and coordination related to drug licenses, renewals, modifications, and approvals.
  • Liaise directly with Drug Inspectors, State FDA, CDSCO, and other regulatory authorities.
  • Ensure timely submission of applications and compliance reports as required under the law.
  • Maintain and update all licenses pertaining to Schedule X, NDPS, wholesale, retail, and institutional distribution.

Compliance & Documentation

  • Ensure strict adherence to NDPS Act, Schedule X, D&C Act, and all pharmaceutical regulatory frameworks.
  • Prepare, maintain, and audit all statutory registers, forms, stock records, inspection files, and regulatory audit documents.
  • Coordinate for inspections, audits, and follow-up actions based on audit findings.
  • Maintain compliance records for manufacturing, procurement, storing, and selling controlled substances.

Coordination & Communication

  • Act as the primary point of contact for regulatory authorities and internal departments.
  • Work closely with QA, supply chain, warehousing, and sales team for regulatory approvals and documentation needs.
  • Ensure timely communication of regulatory changes and updates to management.

Operational Support

  • Support sales and operations teams with documentation required for tenders, institutional supplies, or controlled drug movement.
  • Assist in training internal teams on compliance procedures and regulatory documentation accuracy.

Required Skills & Qualifications:

  • B.Pharm (Mandatory)
  • 5–7 years of experience in regulatory affairs, drug licensing, NDPS/Schedule X compliance, or pharmaceutical operations is mandatory.
  • Strong understanding of Drug & Cosmetics Act, NDPS Act, licensing procedures, and related regulatory mechanisms.
  • Experience handling Drug Inspectors and supporting onsite inspections.
  • Excellent documentation, record-keeping, and communication skills.
  • Ability to work independently and handle regulatory tasks with accuracy and professionalism.

Key Competencies:

  • Regulatory knowledge & compliance orientation
  • Strong coordination & stakeholder management
  • Attention to detail & documentation accuracy
  • Problem-solving and follow-through skills
  • Professional communication with authorities

Job Type: Full-time

Pay: ₹50, ₹60,000.00 per month

Benefits:

  • Provident Fund

Work Location: In person

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