Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Location:

Employment Type:

About Caritas Healthcare Pvt. Ltd.

manufacture, supply, and marketing of cutting-edge pharmaceutical products

At Caritas, we foster an inclusive work environment where diverse perspectives are valued, and employees are empowered to excel.

Position Summary

Senior Regulatory Affairs Specialist

Key Responsibilities

• Compile and review registration dossiers aligned with country-specific regulatory guidelines.
• Prepare, compile, and critically assess high-quality regulatory submissions (e.g., CTD, eCTD) for product approvals and renewals.
• Conduct thorough reviews of technical documents including DMF, PDR, BMR/BPR, Spec/STP, AMV, BE, and stability data.
• Compile comprehensive deficiency responses to address regulatory queries.
• Prepare and submit variations for post-approval changes in compliance with current regulatory requirements.
• Coordinate proactively with overseas regulatory teams, agents, and distributors to ensure timely filings.
• Review artwork for commercial supplies and new product launches to ensure regulatory compliance.
• Maintain and update internal regulatory documentation and databases systematically.
• Monitor global regulatory developments and assess their potential impact on product portfolios.

Required Qualifications and Experience

• Bachelor’s or Master’s degree in Pharmacy (B. Pharm / M. Pharm).
• 2-3 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry.
• Demonstrated experience managing regulatory submissions specifically for LATAM, ASEAN, and African markets.

Preferred Skills and Attributes

• In-depth regulatory and technical knowledge of pharmaceutical product dossiers and international submissions.
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills tailored to regulatory contexts.
• Proven ability to work independently and collaboratively within a fast-paced, global environment.

Why Join Caritas Healthcare?

• Become part of a purpose-driven organization with a truly global footprint.
• Collaborate with seasoned professionals and industry leaders committed to innovation.
• Gain continuous professional development and international exposure to enhance your career.
• Contribute meaningfully to expanding access to vital medicines in diverse global markets.
• Thrive in an inclusive and empowering workplace culture dedicated to diversity and growth.

Application Process

ramesh@caritashealthcare.in

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