Regulatory Affairs Specialist - US Market (Formulation RA)

Role -

Level - AssIstant Manager/ Deputy Manager - US Market

Required Education/Ex

Experience Req.: 7 - 10 yrs.

Sc.

Responsibiliti

• 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 submis

  sion.

Required sk

• Hands on ANDA/ANDS Filing expertise.
• A stable candidate from Pharma company.
• Should have exp of US Submissions.
• Well versed with regulatory gui

  delines.

Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com

Kindly mention below details while

• Total Exp?
• Current CTC?
• Total number of ANDA/ANDS filings?
• Handling Pre-approval activities or not?
• Notice Period?
• Ready to work in Bangalore (onsite) ? (5 Days working)