Senior Executive Regulatory Affairs

Year    Daman, DD, IN, India

Job Description

Preparation of registration, re-registration dossiers, tender documentation, technical queries reply, post-registration activities such as variations for Markets Organization & provision of technical documentation & samples for various tenders within stipulated time frame

Co-ordination with various departments such as Quality Assurance, Quality Control, Planning dept., Production dept., R & D, Packaging development dept., Marketing dept., Analytical development Labs, various locations dept. Administrative depts., for collection of various technical documents as required for registration & Tender purpose.

To interacts with worldwide, federal, state, and local regulatory agencies registration, development, manufacturing, marketing and labeling etc medical products are conducted in compliance with all applicable rules to assure the licensing, of pharmaceutical and

Maintenance of country related registration correspondence like Product permission and COPP application, marketing authorization certificates, registration status, etc.

Review of technical documents on receipt from different location before inclusion in dossiers.

Preparation of technical queries responses raised by different regulatory health authorities

Pre-development work includes sourcing of product information for preparing literatures,

designing and checking of artwork and text matter, development of packing materials.

Monitoring post-registration activities such as variations, amendments, artworks etc

Keep up-to-date with changes in regulatory legislation and guidelines

Any additional responsibility as assigned by the management.

Job Type: Permanent

Pay: ₹25,000.00 - ₹50,000.00 per month

Benefits:

Flexible schedule Food provided Leave encashment Paid sick time Paid time off Provident Fund
Work Location: In person

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Job Detail

  • Job Id
    JD4963229
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Daman, DD, IN, India
  • Education
    Not mentioned
  • Experience
    Year