We are urgently Hiring for Global Inhalation Team for its US back office.

Job description :

Complete technical writing, including creation of specifications, method and method qualification report.

Prior experience in Inhalation products (Nasal/MDI/DPI) is basic requirement.

• Understanding of the data pertaining to Analytical and Product development.
• Write and review analytical methods, analytical method validation protocols and reports using the defined templates and formats
• Prepare raw materials, excipients, packaging materials and drug product specifications.
• Compilation of analytical and formulation documents submitting in Regulatory Filing.
• Preliminary compilation of Query Response from analytical and formulation perspective.
• Preferable to have knowledge of Industry Guidelines, e-CTD submissions and ANDA submissions.