Regulatory Affairs Jobs at Caplin Point - 06 vacancies

Caplin Point was established in 1990 to manufacture a range of ointments, creams and other external applications. The Company was listed in 1994 following its Initial Public Offering (IPO) which was oversubscribed 117 times, the proceeds of which were deployed in setting up a manufacturing facility at Pondicherry. Thereafter, the Company expanded its product range and increased its production capacity. The Company focused on the emerging markets of Latin America, Caribbean, Francophone and Southern Africa and is today one of the leading suppliers of Pharmaceuticals in these regions, with over 2800 product licenses across the globe.

Department : Regulatory Affairs

Experience : 2-6 years
No of Positions : 6 No's
Market Exposure : US / Canada / Europe
Location : Hyderabad & Chennai

Key Responsibilities
• Responsible for Authoring and review of dossiers for submission to US, Canada, Europe, Australia, South Africa and other regulated markets
• Review of DMF's, technical documents and coordinate with CFT's to ensure the submission requirements
• Responsible for Change assessments and provide regulatory filling strategy for Post approval submissions
• Responsible for authoring and review of PLCM submission to maintain compliance to approved MA's