Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan.
- Vacancy details:
- Department: Formulation Regulatory Affairs
- Qualification: M.Sc. / M. Pharma.
- Experienced: 11 – 16 yrs.
- Salary:  ₹Not Disclosed
Job Description: Greetings from Biocon limited .!!
Important Details :
- Location:Â US / Canada
- Post of date:22/08/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Role – Formulation Regulatory Affairs
Role – US / Canada Market Level – Associate Manager / Manager – US Market
Required Education/Exp:
Experience Req.: 11 – 16 yrs.
Qualification: – M.Sc. / M. Pharma.
Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.
Experience and knowledge on life cycle management for the products filed in US market.
Comprehensive and up-to-date knowledge on regulatory guidelines/requirements.
Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.
Responsible to understand the requirements related to US regulatory submissions.
Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received.
Publishing the necessary regulatory dossiers into eCTD format as per the country requirement.
Review of technical (developmental and plant) documentations required for dossier submission.
Candidates with relevant exp.,
kindly share CVs to apply on :- rashmi.gupta@biocon.com
Required skills :- Hands on ANDA/ANDS Filing expertise A stable candidate from Pharma company Should have exp of US Submissions Well versed with regulatory guidelines. Candidates with relevant exp.
kindly share CVs to apply on :- rashmi.gupta@biocon.com
