Regulatory Affairs Specialist

7 days ago


Bengaluru, Karnataka, India Biocon Full time
We are hiring for dynamic individuals in

Regulatory Affairs Department:
Experience: 3 years up to 12 years Designation: Senior Exec / Assistant Manager /

Deputy Manager Qualification:
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 Market Deficiency management for products filed in US / Canada Providing regulatory strategies / inputs Role 3: Formulation Regulatory Affairs – US / Europe ~ post
  • Approval Preparation & timely submission of: Supplements/variations for global markets.
Post approval Deficiency response & Life cycle management PADER/PSURs & Annual Reports Hands onChange 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 / for an interview opportunity within 3-4 days.



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