Regulatory Specialist

We are looking for a Regulatory Specialist Experience in regulatory affairs, preferably with QA (Quality Assurance) and PV experience

Apply to this Link : Dr Reddy's Laboratories Limited is looking for: RA Specialist in Bangkok, Thailand. https://jobs.smartrecruiters.com/DrReddysLaboratoriesLimited/744000102233376-ra-specialist

• Bangkok, Thailand
• Full-time
• Job Family: Regulatory Affairs
• Sub Job Family: Regulatory Affairs General
• Business unit: GG EM
• Years of Experience: 1-3

Company Description

Good Health Can't Wait

By joining Dr Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

NOTE: This role is for local Candidates/ Thai Resources only, not for Expats

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.

Qualifications

Qualifications, Experience, Skills & Attributes

Educational qualification: A Bachelor of Science in Pharmacy or Industrial Pharmacy; OR Pharmacy professional license holder

Minimum work experience: 1 to 3 years of experience in regulatory affairs, preferably with QA (Quality Assurance) and PV experience

Skills & attributes:

• 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.