Require Regulatory Affairs Assistant Manager at Naprod Life Sciences

Naprod Life Sciences is a dominant player in the Oncology and Anesthesia space not only in India but also globally. Naprod’s vision is to become a world-class player in Oncology through excellence in innovation, the discovery of new manufacturing processes/drug delivery mechanisms and a consistently high quality of production.

Post : Asst.Manager Regulatory Affairs

Job Description:
• Hands on experience on preparation, review and timely submission of ROW market.
• Comprehensive and up-to-date knowledge on regulatory guidelines/requirements.
• Identify relevant guidance documents, international standards and provide interpretive assistance.
• Providing necessary regulatory inputs to different cross functional teams during different stages of product development and manufacturing.
• Experience and knowledge on life cycle management for the products filed in ROW Market
• Review of technical (developmental and plant) documentations required for dossier submission.
• responsible to work on deadlines, in a fairly high pressure business environment while being a good team member
• ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy
• Lead team for timely results
• Experience in balancing customer facing role and work assessments
• Self-starter and have analytical, prioritisation skills
• Good analytical, Communication skills and business acumen.
• Exposure in Regulatory approved companies from ANVIMA, ANVISA, WHO, FDA etc.
• Expected Output (Quantitative/Qualitative) from the role in current or next 1 year
• Limited query from Agents & MOH
• Support Business development team by getting on time registrations

Additional Information
Experience : 5+ years
Qualification : B.Pharma
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
Salary: 10 lpa
End Date : 2nd December, 2020