Biocon is global biopharmaceutical company changing patients' lives in over 120 countries by finding new and affordable ways to treat diabetes, cancer and autoimmune diseases. Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain.
Department - Regulatory Affairs
Job Location - Bangalore
Formulation RA US / Canada - Pre-Approval
Experience & Education : 6-10 years ; B.Pharm / M.Pharm
Job Profile : 1. Preparation, review & timely submission of ANDA in US
2. Deficiency & life cycle management for products filed in US
3. Provide necessary regulatory inputs to different cross-functional teams (including CMO & CDMO projects)
Formulation RA Global Post-Approval
Experience & Education : 2-8 years ; B.Pharm / M.Pharm
Job Profile : 1. Preparation, review & timely submission of supplements / variations for global markets
2. Preparation, review & submission of post approval deficiency management
3. Handle change control assessments to provide necessary regulatory inputs for changes / strategies proposed
4. Preparation, review, compilation & submission of PADER / PSURs & Annual Report for all approved products across geographies as applicable
Formulation RA Global Labelling
Experience & Education : 1 -4 years ; B.Pharm
Job Profile : 1. Management of labelling- & artwork-related activities for global markets (US/EU/UK and RoW)
2. Handle change control assessments for the artworks
3. Hands-on experience in handling SPL software for labelling activities
API RA DMF Submission
Experience & Education : 5-14 years ; MSc / M.Pharm / B.Pharm
Job Profile : 1. DMF submission to global markets & handling health authority queries
2. Handle post approval changes
3. Provide regulatory input for new molecule development
4. Customer queries and support
Walk in Interview
Date : 24th February 2024, Saturday
Time : 9:00 am to 2:00 pm
Venue : Biocon Campus - Gate No. 1, Phase 1, 20th Km, Hosur Road, Electronic City, Bangalore - 560100, Karnataka
Important
1. Candidates who have attended an interview with Biocon Limited over the last six months are not eligible to apply
2. Candidates must carry their updated resumes, certificate of their highest educational qualification, latest increment letter and the last three month's pay slips
Interested candidates can email their resumes to upendra.kamma@biocon.com for an interview opportunity.
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