Biocon
Biocon Limited, a global leader in fermentation derived APIs. We are hiring for Regulatory Affairs positions in Formulation and API sections. Qualifications: M.Sc/B.Pharm/M.Pharm with 1-10 years of experience. Walk-in interviews on 24th February 2024 at Biocon Campus, Bangalore.
We are conducting walk-in interview for various positions in Regulatory Affairs on 24th February 2024.
Formulation Regulatory Affairs – US/Canada Pre-Approval
Experience: 6-10 years
Qualification: B Pharm/ M Pharm
JOB PROFILE:
- Preparation, review and timely submission of ANDA in US.
- Deficiency and life cycle management for products filed in US.
- Provide necessary regulatory inputs to different cross-functional teams (including CMO and COMO projects)
Formulation Regulatory Affairs – Global Post-Approval
Experience: 2 – 8 years
Qualification: B Pharm / M Pharm
Job Profile:
- Preparation, review and timely submission of supplements/variations for global markets
- Preparation review and submission of post approval deficiency management
- Handle change control assessments to provide necessary regulatory inputs for strategies/changes proposed
- Preparation, review, compilation and submission of PADER/PSURs and Annual Report for all approved products across geographies as applicable.
Formulation Regulatory Affairs Global Labelling
Experience: 1-4 years
Qualification: B Pharm
Job Profile:
- Management of labelling and artwork-related activities for global markets (US/EU/UK and RoW)
- Handle change control assessments for the artworks
- Hands-on experience in handling SPL software for labelling activities
API Regulatory Affairs DMF Submission
Experience: 5 – 14 years
Qualification: M Sc / M Pharm B Pharm
Job Profile:
- DMF submission to global markets and handling health authority queries
- Handle post approval changes
- Provide regulatory input for new molecule development
- Customer queries and support
Walk-In Interview Details:
Date of interview: 24 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, Karnataka – 560100.
Please Note:
- Candidates who have participated in an interview with Biocon Limited within the past six months will not be considered eligible for application.
- Candidates are required to bring along their updated resumes, the certificate of their highest educational qualification, the most recent increment letter, and the last three months’ pay slips. For those interested,
To apply for this job email your details to upendra.kamma@biocon.com