Dr. Reddy’s Laboratories Regulatory Affairs Associate Job – Life Sciences, Bioinformatics Apply

Dr. Reddy’s Laboratories Bioinformatics Jobs – Apply Online For Regulatory Affairs Associate Role

Regulatory Affairs Associate

Greater Kolkata Area

Job Summary

We are looking for an individual to carry out core regulatory activities, including dossier finalization, filing regulatory applications, internal liaison for regulatory information compilation, coordination with Quality Assurance teams during audits, and ensuring regulatory compliance and systems.

Roles & Responsibilities

• You will be responsible for the finalization of dossiers, including drafting, compilation, archival, and following systems and SOPs (Standard Operating Procedure) related to dossier management.
• You will execute the filing of study applications (toxicity studies, clinical studies, marketing authorizations), manage administrative requirements for filing, handle query responses, process specific permissions at the Ministry of Science and Technology and the Ministry of Health, such as licenses of import/export, test, commercial, or permits.
• You will be an internal liaison for the compilation of regulatory information for dossiers and query responses, working closely with CMC (Chemistry, Manufacturing, and Controls), NC (Non-Clinical), and clinical SMEs (Subject Matter Experts) to collect and transact information necessary for compilation.
• You will be responsible for coordinating with Quality Assurance teams during audits, actively participating in audits to transact regulatory information that supports facility inspections.
• Your responsibilities include executing IBSC (Institutional Biosafety Committee) activities and reporting compliance to the Ministry of Science and Technology, and drafting and implementing SOPs for key regulatory processes.
• You will be responsible for drafting and compiling regulatory compliance correspondences as per country regulations, particularly related to CMC (APQR’s – Annual Product Quality Reviews, PAC’s – Post Approval Changes) & Clinical (Phase 4, PSUR’s – Periodic Safety Update Reports, PIL’s – Patient Information Leaflets, IB’s – Investigator’s Brochures, compensation reports, etc.).
• You will be involved in designing, customizing, and maintaining regulatory information systems such as SharePoint, Electronic Common Technical Document (eCTD), and Document Management System (DMS).

Qualifications

Educational Qualification: A Master’s degree in any of the life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, Regulatory Affairs, Pharmacy, etc.); Bachelor’s will be considered if there is sufficient prior experience.

Minimum Work Experience: 2 years of experience in regulatory affairs; total 6 years in biologics/biosimilar research and development is good to have.

Skills & Attributes

Technical Skills

• Ability to stay up-to-date with business priorities and a skill to calibrate strategies against the changing dynamics of the business environment.
• Good understanding of Information Technology (IT) platforms supporting regulatory activities, including eCTD, DMS, and Regulatory Information Management System (RIMS).
• Knack for analyzing regulatory information to identify risks, demonstrating the ability to assess regulatory data critically and identify potential challenges or areas of concern.

Behavioural Skills

• Possesses strong negotiation skills, cultural sensitivity, and excellent interpersonal skills.
• Pays meticulous attention to detail in tasks and responsibilities.
• Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health (MOH).
• Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.

APPLY ONLINE HERE

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