Dr.Reddy's Lab looking for Regulatory Affairs Specialist

Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process.

Post : RA Specialist

Job Description
Job Summary
Regulatory Affairs Specialist will oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals. This role is pivotal in managing activities pertaining to product lifecycle management, quality management and pharmacovigilance, including variations and renewals, SOP development, risk management, and trainings. Collaboration with internal teams will be essential for supporting internal and external audits and implementing effective CAPA measures.

Roles & Responsibilities
• Preparation and submission of the regulatory dossier.
• Delivering registration goals with minimum supervision.
• Monitoring and follow-up of product filings for early approval of applications.
• Revision of artworks, including prescribing information to ensure regulatory compliance.
• Product lifecycle management, including variations, renewals and post-approval commitments.
• Participating in the industry association to keep abreast of regulations.
• Creation and revision of new or existing SOPs (Standard Operating Procedures).
• Management of quality activities, including product release, handling complaints, deviations, self-inspection of change controls, trainings, documentations, and risk management.
• Management of PV (Pharmacovigilance) activities such as adverse event monitoring.
• Audit of third-party distributors.
• Supporting internal and external audits and implementation of CAPA (Corrective and Preventive Actions).
• Developing and maintaining a good internal and external network.
• Performing other tasks and duties assigned by the immediate supervisor.

Candidate Profile
• A Bachelor of Science in Pharmacy or Industrial Pharmacy ; Pharmacy professional license holder
• 1 to 3 years of experience in regulatory affairs, preferably with QA (Quality Assurance) and PV experience
• Knowledge of FDA guidelines.
• Proficiency in spoken and written English.
• Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
• Excellent interpersonal and communication skills.
• Attention to detail and the ability to multi-task and meet strict deadlines.

Additional Information
Experience : 1 to 3 years
Qualification : Bachelor of Science in Pharmacy
Location : BANGKOK
Job Family : Regulatory Affairs General
End Date : 30th April 2026