Position: Regulatory Affairs (Formulation)
Industry: Pharmaceutical & Life Sciences
Department: Research & Development
Employment Type: Full-Time, Permanent
Role Category: Pharmaceutical & Biotechnology
Interview Date: Sunday, 25th August 2024
Interview Time: 9:30 AM – 1:00 PM
Interview Venue: Sun Pharmaceutical Inds Ltd, Near Akshar Chowk, Sun Pharma Road, Tandalja – Baroda 390012

Overview:

Sun Pharmaceutical Industries Ltd is conducting a walk-in interview for the role of Regulatory Affairs (Formulation) with a focus on product registrations for the US, EU, and Canada markets. This is an excellent opportunity for experienced professionals to join a leading pharmaceutical company and contribute to the regulatory submission process for various health authorities.

Key Responsibilities:

• Review & Compilation: Review all data and documents related to product registrations, with a preference for non-oral formulations. Compile registration dossiers for submission to health authorities in the US, Canada, Europe, and Australia.
• Regulatory Submissions: Prepare and submit responses to deficiency letters received from various regulatory agencies. Ensure that all submissions meet the specific requirements of each health authority.
• Post-Approval Changes: Maintain life-cycle management and post-approval changes for drug product registration dossiers, ensuring compliance with regulatory guidelines.
• Cross-Functional Support: Provide regulatory support to cross-functional departments, ensuring that all regulatory requirements are met throughout the product development and registration process.
• Scientific Advice: Prepare and submit scientific advice to various health authorities, facilitating clear communication and compliance with regulatory expectations.
• eCTD Compilation & Submission: Compile, verify, and submit electronic Common Technical Document (eCTD) dossiers through electronic gateways, ensuring accuracy and compliance with regulatory standards.

Key Requirements:

• Experience: Previous experience in Regulatory Affairs, particularly in formulation development and product registrations for US, EU, and Canada markets.
• Technical Expertise: Strong understanding of regulatory requirements and submission processes, including eCTD compilation and electronic submissions.
• Communication Skills: Excellent communication skills to interact with regulatory agencies and cross-functional teams effectively.
• Attention to Detail: High level of attention to detail to ensure accuracy in dossier compilation, submission, and response preparation.
• Regulatory Knowledge: In-depth knowledge of regulatory guidelines and requirements for pharmaceutical product registrations in various global markets.

Walk-In Interview Details:

• Date: Sunday, 25th August 2024
• Time: 9:30 AM – 1:00 PM
• Venue: Sun Pharmaceutical Inds Ltd, Near Akshar Chowk, Sun Pharma Road, Tandalja – Baroda 390012