Senor regulatory affairs specialist

Senior Regulatory Affairs Specialist

Location:

About Caritas Healthcare Pvt. Ltd.

manufacture, supply, and marketing of a wide range of avant-garde pharmaceutical products

Role Overview

Senior Regulatory Affairs Specialist

Education & Experience

• Education:

  B. Pharm / M. Pharm

• Experience:

  2-3 experiences in Regulatory Affairs within the pharmaceutical industry preferred

• Markets Handled:

  Specific hands-on experience in LATAM, ASEAN, and African regulatory submissions is essential

Key Responsibilities

• Compilation and review of registration dossiers as per country-specific guidelines and requirements.
• Preparation, compilation, and review of high-quality regulatory submissions (e.g., CTD, eCTD) for product approvals and renewals.
• Review all technical documents (DMF, PDR, BMR/BPR, Spec/STP, AMV, BE, Stability, etc.).
• Compilation of deficiency responses for product submissions.
• Preparation and submission of variations for post-approval changes.
• Review proposals for post-approval changes as per current regulatory guidance.
• Communicate and coordinate with overseas regulatory teams, agents, and distributors to ensure timely filing.
• Review artworks for commercial supplies and new product launches.
• Maintain and update internal regulatory documentation and databases.
• Monitor global regulatory changes and assess their potential impact on products.

Preferred Candidate Profile

• Strong regulatory and technical knowledge
• Proficiency in managing international dossiers and submissions
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a fast-paced environment

Why Join Caritas Healthcare?

• Be part of a purpose-driven organization with a global footprint
• Work alongside experienced professionals and industry leaders
• Play a pivotal role in expanding access to essential medicines worldwide

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