Regulatory Affairs Openings in Hyderabad / Chennai – 06+ Vacancies

Caplin Steriles, a subsidiary of Caplin Point Laboratories, is currently hiring for multiple Regulatory Affairs positions in Hyderabad and Chennai. With over six vacancies available, this is a prime opportunity for professionals with 2-6 years of experience in regulatory affairs to join a dynamic and innovative pharmaceutical company. If you have the qualifications and are looking for a rewarding career in regulatory affairs, read on for more details.

About Caplin Steriles

Company Overview
Caplin Steriles, a division of Caplin Point Laboratories, specializes in sterile dosage forms and has a strong presence in regulated markets like the US, Canada, Europe, Australia, and South Africa. The company is committed to quality and compliance, making it a great place to advance your career in regulatory affairs.

Job Openings in Regulatory Affairs

Location: Hyderabad and Chennai
Experience: 2-6 years
Qualification: Relevant experience in regulatory affairs

Key Responsibilities

Dossier Authoring and Review

• Responsible for the authoring and review of dossiers for submission to regulated markets including the US, Canada, Europe, Australia, and South Africa.
• Ensure compliance with submission requirements by coordinating with cross-functional teams (CFTs).

DMF Review and Coordination

• Review Drug Master Files (DMFs) and technical documents.
• Coordinate with relevant teams to ensure all submission requirements are met.

Change Assessments and Post-Approval Submissions

• Conduct change assessments and provide regulatory filing strategies for post-approval submissions.
• Author and review Product Lifecycle Management (PLCM) submissions to maintain compliance with approved Marketing Authorizations (MAs).

Compliance and Strategy

• Ensure all submissions meet regulatory standards.
• Develop strategies to maintain compliance and streamline submission processes.

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Application Process

Interested Candidates
If you meet the qualifications and are eager to join a leading pharmaceutical company, send your CV to careers@caplinpoint.net.