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Regulatory Affairs Associate

2 weeks ago

Ho Chi Minh City, Ho Chi Minh, Vietnam Septodont Full time ₫30,000 - ₫60,000 per year

About Septodont:

At Septodont, we are spreading smiles worldwide. With over 90 years plus of excellence globally & 25 years domestically, we've been at the forefront of revolutionizing dental care worldwide. Our commitment to quality, innovation, and patient well-being drives us to continually push the boundaries of dental science. As a global leader in dental solutions, we're dedicated to empowering dental professionals and improving patient outcomes everywhere.

Septodont communicates a culture of growth and opportunity, enticing top talent to join its dynamic team. With a focus on nurturing talent, fostering creativity, and promoting diversity in the workplace, Septodont presents itself as a people-oriented employer that looks after the professional development of its team. Aspiring candidates are drawn to the company's reputation for fostering a collaborative environment where ideas flourish and individuals thrive.

Scope of role:
Vietnam/Cambodia/Myanmar

JOB SUMMARY

The Regulatory Affairs Associate supports regulatory affairs activities by handling registration and maintenance of our portfolio, ensuring compliance with health authorities' requirements, and maintaining registration tracking systems. This role will have experience not only working in RA but also PV & QA.

KEY ACCOUNTABILITIES

Regulatory Affairs (70%):

  • Representative on behalf of Corporate Regulatory Affairs of Septodont; be interface between local authorities and Septodont.
  • Registration Documentation Management and Verification:
    Prepare, compile, and orchestrate comprehensive registration files with cross-functional teams, conducting quality checks to ensure compliance with local and international regulatory standards. Help in collecting prerequisites, and other requirements for RA submissions for Septodont's RA activities.
  • Registration Process Administration:
    Process registration applications, certificates, and correspondence, maintaining precise tracking of submission status and regulatory interactions. Collaborate and follow with RA consultants for Septodont's product registrations or life cycle maintenance activities.
  • Market Readiness Support
    : Guide operations and commercial teams through regulatory requirements until product launch, ensuring market compliance and readiness.
  • In collaboration with Septodont corporate RA and RA consultants for proposition of regulatory strategies of Septodont products and adjustments if necessary.
  • Collaborate with Septodont's distributors for local regulatory aspects such as inspection, requirements of compliance from local agencies, customs requests, serialization setup coordination, annual reports coordination, etc.
  • Create and/or check and help in validating the labels, artworks, and leaflets as well as local labels in compliance with the corporate proposition as well as local regulations.
  • Meeting with local authorities on behalf of Septodont.
  • Registration Archive and Information Management:
    Create and maintain structured filing systems for registration documentation, supporting efficient information retrieval and regulatory compliance.
  • Registration Status and Lifecycle Monitoring:
    Develop and maintain detailed tracking systems for product registrations, managing renewal timelines and ensuring continuous market access for product portfolios.
  • To set up a Regulatory intelligence watch system for assigned countries: monitoring local regulations and evaluation of impact for our existing or future products; ensure good understanding and interpretation of local regulation for Septodont's business; participate to local lobbying if necessary.

PV and QA (30%):

  • Local contact person with the GVD department for vigilance.
  • Maintenance of local QMS regarding vigilance.
  • Maintain the Quality Management System.
  • Ensure the right storage and transportation conditions.

Education :

  • Post Graduate or Bachelor's Degree in Sciences (chemistry, pharmacy or health-related majors)

Experiences :

  • Minimum 5 years of similar experiences
  • Understanding the local Vietnam regulations on Drugs & Devices
  • Ability to travel within the assigned region