Job opportunity in Regulatory Affairs Department at Caplin Point – Apply before 31st July 2024

Position: Regulatory Affairs Specialist

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

About Caplin Point Laboratories

Founded in 1990, Caplin Point Laboratories started its journey by manufacturing ointments, creams, and other external applications. Following an Initial Public Offering (IPO) in 1994, which was oversubscribed 117 times, the company established a state-of-the-art manufacturing facility in Pondicherry. Over the years, Caplin Point expanded its product range and production capacity, focusing on emerging markets in Latin America, the Caribbean, Francophone Africa, and Southern Africa. Today, Caplin Point is a leading pharmaceutical supplier in these regions, holding over 2800 product licenses worldwide.

Key Responsibilities

• Dossier Authoring and Review: Prepare and review dossiers for submission to regulatory bodies in the US, Canada, Europe, Australia, South Africa, and other regulated markets.
• Document Review: Evaluate Drug Master Files (DMFs) and technical documents, coordinating with cross-functional teams to ensure submission requirements are met.
• 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).

How to Apply

Send your CVs to: careers@caplinpoint.net
Application Deadline: 31st July 2024

Join us in making a difference in the global pharmaceutical industry. We look forward to receiving your application!

• For more articles, Kindly Click here.
• For pharmaceutical jobs, follow us on LinkedIn

  For more jobs, kindly visit our job section.

  www.pharmaceuticalcarrier.com/Job