Executive / Officer - Regulatory Affairs

Key Responsibilities:

• Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats.
• Setting specifications of API process development, knowledge of litigation related to Drugs and Cosmetics Act.
• Filing annual updates and amendments to various regions of submitted DMFs.
• Handling queries obtained from different regulatory agencies and customers.
• Compilation, preparation and review of Technical Package of API's.
• Compliance to audits of regulatory bodies especially USFDA and EU.
• Generation of documents from R&D, Production, QC and QA of newly developed API's.

Administrative Duties:

• Responsible for record keeping and to ensure correctness of records pertaining to department.
• Responsible for all type of computer work and follow-ups.
• Carrying out the initial assessment of Vendor Questionnaire and relevant documents.
• Maintain housekeeping and cleanliness of plant.
• To impart scheduled trainings of ICH guidelines pertaining to department.

Job Requirements:

• Desirable: Minimum 03 to 05 years working experience B. Pharma/M. Pharma
• Location: Murthal, Sonipat.