JOB DETAILS

RA Specialist

CompanyDr Reddy's Laboratories Limited
LocationBangkok
Work ModeOn Site
PostedMarch 30, 2026
About The Company
Established in 1984, we are a global pharmaceutical company headquartered in Hyderabad, India. Driven by our purpose of ‘Good Health Can’t Wait’, we work to provide access to affordable and innovative medicines. We offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major markets include USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in future growth drivers such as access to novel molecules, digital therapeutics and consumer healthcare. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. Caution Notice: Dr. Reddy's has been made aware of candidates receiving fraudulent job opportunities from unauthorised recruiting agencies or people impersonating Dr. Reddy's leaders. These fraudulent jobs may be advertised on employment sites or mimic our careers site and company email addresses. Please know that Dr. Reddy's Laboratories has no affiliation or connection to these situations. Dr. Reddy's (and its associated/group companies) follows a formal recruitment process through its own HR department. Please report immediately in case you suspect a fraudulent job. You may raise your concern by: Accessing https://drreddys.ethicspoint.com.  Calling on the hotline number. List of hotline numbers are available in https://drreddys.ethicspoint.com. The hotline is available 24x7 in multiple languages.  Writing to complianceofficer@drreddys.com or chiefombudsperson@drreddys.com. For our community guidelines on LinkedIn, please visit: https://shorturl.at/LTvNZ
About the Role

Company Description

About Dr Reddy’s

At Dr Reddy's "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.

Job Description

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; 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.
  • Job Family: Regulatory Affairs
  • Sub Job Family: Regulatory Affairs General
  • Preferred type of working: On-Premise
  • Years of Experience: 3 - 6
  • Business unit: GG EM
    • Key Skills
    Regulatory Dossier PreparationProduct Lifecycle ManagementQuality ManagementPharmacovigilanceSOP DevelopmentRisk ManagementAudits SupportCAPA ImplementationFDA Guidelines KnowledgeEnglish ProficiencyMS ExcelInterpersonal SkillsCommunication SkillsAttention To DetailMulti-taskingDeadline Management
    Categories
    HealthcareScience & ResearchLegalAdministrative
    Job Information
    📋Core Responsibilities
    The Regulatory Affairs Specialist will manage the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals, while overseeing product lifecycle management, quality, and pharmacovigilance activities. This role involves creating and revising SOPs, managing quality activities like deviations and change controls, and supporting internal and external audits.
    📋Job Type
    full time
    📊Experience Level
    2-5
    💼Company Size
    31988
    📊Visa Sponsorship
    No
    💼Language
    English
    🏢Working Hours
    40 hours
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