Job Details:

Department: Regulatory Affairs
Experience: 2-6 years
Number of Positions: 6
Market Exposure: US / Canada / Europe
Location: Hyderabad & Chennai

Key Responsibilities:

• Authoring and Review of Dossiers: Prepare and review dossiers for submission to regulatory authorities in the US, Canada, Europe, Australia, South Africa, and other regulated markets.
• Review of DMFs and Technical Documents: Ensure that all Drug Master Files (DMFs) and technical documents meet submission requirements by coordinating with cross-functional teams.
• Change Assessments: Conduct change assessments and develop regulatory filing strategies for post-approval submissions.
• PLCM Submissions: Author and review Product Lifecycle Management (PLCM) submissions to maintain compliance with approved Marketing Authorizations (MAs).

Application Details:

Send your CVs to: careers@caplinpoint.net
Last Date to Apply: 31st July 2024

This is an excellent opportunity for individuals with a background in regulatory affairs and market exposure to the US, Canada, and Europe. If you meet the qualifications and are interested in contributing to Caplin Point’s continued growth, apply before the deadline.