Roles & Responsibility
· Hands on experience in preparation and submission of dossiers in SRA countries (EU 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 Regulated 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, prioritization skills
· Customer centric
· Good analytical, Communication skills and business acumen.
· Experience in handling Oncology Injectable
· Total Experience : 4 to 7 Yrs
Qualification: M. Pharm
Pay: ₹600,000.00 - ₹750,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
