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Senior Regulatory Affairs Executive

3+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Regulatory Affairs Executive

Job ID: 19912
Location: Bangkok, Thailand
Organization: Boehringer Ingelheim Animal Health (Thailand) Limited
Job Function: Regulatory Affairs
Career Level: Experienced Professionals
Working Time: Full-Time
Job Flexibility: Hybrid


Position Overview

As a Senior Regulatory Affairs Executive, you will be responsible for the complete lifecycle of product registration in Thailand. This includes ensuring that all regulatory requirements are met for both product registration and post-approval variations. You will also support business marketing activities through promotional material applications, manage packaging component artwork for registered products, and oversee the certification process for biological and vaccine products.


Key Responsibilities

  • Product Registration & Coordination:
    • Manage and ensure the timely registration of products in compliance with Thai regulatory requirements.
    • Handle the entire product lifecycle, from initial registration to post-approval variations.
  • Marketing & Promotional Compliance:
    • Apply for promotional material approvals to support marketing activities while ensuring compliance with local regulations.
  • Packaging & Artwork Management:
    • Oversee the packaging components and artwork for registered products, ensuring compliance with regulations and internal processes.
  • Certification & Lot Release:
    • Apply for the Certificate of Lot Release for biological and vaccine products, ensuring products are ready for sale on time.

Qualifications & Requirements

  • Experience:

    • Minimum of 3 years experience in Regulatory Affairs within the pharmaceutical industry.
  • Education:

    • Bachelor’s degree or equivalent in Pharmacy. Additional education in Management is a plus.
  • Skills & Knowledge:

    • Strong knowledge of Regulatory Affairs in the pharmaceutical sector.
    • Proficiency in English language skills.

Why Boehringer Ingelheim?

  • Innovation:
    Boehringer Ingelheim develops breakthrough therapies aimed at improving the lives of humans and animals.

  • Culture:
    The company fosters a diverse, collaborative, and inclusive culture. Innovation is at the heart of everything, and learning & development are key to growth.

  • Global Perspective:
    Boehringer Ingelheim is a global employer that provides challenging and rewarding opportunities with a long-term perspective.

  • Career Growth:
    As part of the Boehringer Ingelheim team, you will have opportunities for learning and development, advancing your career within a supportive environment.


How to Apply

Click the “Apply Now” button to submit your application. For further details, visit Boehringer Ingelheim’s website.


Additional Information

  • Boehringer Ingelheim is an equal opportunity employer that embraces diversity in its workforce and strives for an inclusive environment.