Exposure to both local and international regulatory frameworks.
To shape RA strategy and build relationships with key government stakeholders.
About Our ClientA leading multinational healthcare company with a strong presence in pharmaceuticals and medical devices. Known for its commitment to quality, innovation, and regulatory excellence, the organization offers a dynamic environment for professionals seeking impactful roles in compliance and product lifecycle management.Job Description
Prepare, assess, and review product registration dossiers, coordinating with internal teams and international affiliates.
Analyze and respond to regulatory authority feedback (e.g., FDA, TISI), ensuring timely and compliant submissions.
Manage variations in registration data (e.g., indications, technical updates, safety data) in line with current legal requirements.
Support marketing teams in obtaining advertising approvals and ensure promotional materials comply with regulatory standards.
Review and prepare artwork, labels, and package inserts to align with approved documents.
Communicate registration status updates and coordinate with relevant departments to support product importation and distribution.
Maintain regulatory documentation systems (both digital and physical) for audit readiness and legal reference.
Monitor and report on regulatory changes; assess impact and communicate updates to internal stakeholders.
Build and maintain strategic relationships with regulatory authorities to facilitate smooth approvals and long-term collaboration.
Collaborate with QA to ensure post-approval compliance and product lifecycle management.
Identify and resolve regulatory challenges, continuously improving RA processes.
Coach and support junior RA staff (Associates, Officers, Admins).
The Successful ApplicantA successful RA Manager should have:
Bachelor's degree in Pharmaceutical Sciences with a valid Pharmacist License (Master's degree is a plus).
Minimum 5 years of solid experience in pharmaceutical regulatory affairs, preferably in multinational companies.
Strong experience in both New Drug and Generic Drug registration.
Excellent command of English.
Strong interpersonal and communication skills, with the ability to collaborate across functions.
High attention to detail, accuracy, and ability to manage ambiguity in a fast-paced environment.
Strategic, business-driven mindset with a focus on delivering results.
What's on Offer
Competitive salary in the range of 1,400,000 THB to 1,560,000 THB annually, and attractive benefits.
Opportunities to work in a leading organisation within the pharmaceutical industry.
An engaging work environment focused on innovation and compliance.
If you are ready to take the next step in your career as an RA Manager, apply today to join a reputable organisation in the pharmaceutical sector.ContactJiraprapa LaonamsaiQuote job refJN-082025-6816925Phone number+66 2 012 5098Job summary Sector Specialisation What is your area of specialisation? Location Contract Type Consultant name Jiraprapa Laonamsai Consultant phone +66 2 012 5098 Job Reference JN-082025-6816925
