Regulatory Affairs Specialist
Job details
We are hiring for dynamic individuals in Regulatory Affairs Department:Experience: 3 years up to 12 yearsDesignation: Senior Exec / Assistant Manager / Deputy ManagerQualification: M. Sc. / M. Pharma/ B. Pharma For Below Mentioned roles: -Role 1: - API Regulatory Affairs - DMF filing / Submission. submission to global markets & handling health authority queries.Post approval changes.Regulatory input for new molecule development.Customer queries and support.Role 2: Formulation Regulatory Affairs - US/Canada Market ~ Pre-Approval Preparation & Submission of ANDA Filing in US / Canada MarketDeficiency management for products filed in US / CanadaProviding regulatory strategies / inputsRole 3: - Formulation Regulatory Affairs - US / Europe ~ post-ApprovalPreparation & timely submission of: - - Supplements/variations for global markets.- Post approval Deficiency response & Life cycle management- PADER/PSURs & Annual ReportsHands on Change control assessments.Role 4: - Formulation Regulatory Affairs - Emerging Markets Expertise in registration in various emerging markets.Capable of handling queries and well versed in Risk mitigation.Post - Approval Life cycle management.Candidates interested in accelerating their Career in Biocon, can email their resumes with their CTC to rashmi.gupta@biocon.com / Upendra.kamma@biocon.com for an interview opportunity within 3-4 days. PRB
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