Manager, Regulatory

7 days ago

Bangkok, Bangkok, Thailand Bausch Health Companies Inc. Full time

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

Job Description:

  • Work as a regional RA leader to prepare registration strategy, submission plan and coordinate registration submissions in APAC, Thailand, Philippines, Malaysia, Singapore, as well as other south east Asia countries;
  • Lead country team and global team to prepare submission dossiers, interact and coordinate the interaction with different health authorities;
  • Work as a key contact point for APAC regulatory intelligence, proactively search and monitor policy and regulation changes from health authorities, work with cross functions to analyze the impact of regulatory environment changes to the companys products and business, and update to key stakeholders timely;
  • Overall monitor the registration projects in ASEAN countries, make sure product approvals on time, timely update and report to all stakeholders;
  • Review and approve advertising, promotional materials and labeling to ensure regulatory compliance;
  • Maintain QMS and certification within the sites, including the the control of quality procedures and records
  • Oversee quality processes such as product releases, product re-labelling, complaint investigations and reporting, change control, non-conformance, correct and preventive actions.
  • Monitor 3PLs, suppliers, service providers and distributors with regards to maintenance of product quality and compliance to quality procedures, through regular checks and audits
  • Create quality awareness and educate and train employees on the organization QMS, local regulations and certification requirements
  • Ensures each sites audit readiness and manage external regulatory and corporate inspections to ensure full compliance. Coordinate internal audits within the sites
  • Escalate critical quality issues and lead any field service corrections / market actions
  • Perform post-marketing materiovigilance activities such as reportability assessments for complaints, submission of medical device event reports as required by applicable local laws and regulations, respond to regulatory agencies inquiries on serious Injury and/or Device Malfunction.

Qualifications:

  • Bachelor degree or above in life science, engineering or mechanical discipline;
  • 8-10 years regulatory affairs experience in MNC, familiar with medical device registration in ASEAN countries, other APAC countries in a plus;
  • Good project management and interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment;
  • Experience of active device registration, laser or RF device registration is a plus, aesthetic device is a plus;
  • Basic ISO9001, ISO 13485, GMP and GDP knowledge, auditing Skills (preferred)
  • Fluency in written and spoken English, other languages in ASEAN countries is a plus.

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

  • Regulatory Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand LSI Corporation Full time ฿1,200,000 - ฿2,400,000 per year

    Arxada is a global specialty chemicals business that's committed to solving the world's toughest preservation challenges through better science. [With a proud history of innovation dating back more than a century], we aim to help our customers develop more sustainable solutions that protect and maintain the health and wellbeing of people and extend the life...

  • Regulatory Affairs Manager

    3 days ago

    Bangkok, Bangkok, Thailand Private Advertiser Full time

    Job SummaryOur client, a Leading multinational pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to lead and oversee all regulatory activities in Thailand. This role is critical in ensuring compliance, driving successful product registrations, and maintaining strong relationships with the Thai FDA.Key ResponsibilitiesManage all...

  • Regulatory Compliance Manager

    3 days ago

    Bangkok, Bangkok, Thailand Chronos Consulting Full time

    Regulatory Compliance Manager (Urgent)On-site, based in Bangkok (BTS line)The Company:Chronos Consulting is part of the Coberon Chronos Group, an award-winning global leader in permanent and temporary staffing, RPO, and business process automation solutions for global multinationals. The Group owns and operates 52 offices worldwide.Chronos Consulting's...

  • Regulatory Compliance

    2 weeks ago

    Bangkok, Bangkok, Thailand Krungsri Full time ฿1,200,000 - ฿2,400,000 per year

    Job Descriptions:Managed relationship and exam/ inspection reviewed with all regulators and partners and ensure inspection preparedness.Provided compliance advice/support on a variety of complex regulations (e.g. BOT, AML/CFT, OIC, NCB, OCPB, payment regulations, consumer protection, technology, information security, credit information and privacy, data...

  • Regulatory Affairs

    1 week ago

    Bangkok, Bangkok, Thailand coins Full time ฿400,000 - ฿1,200,000 per year

    Join the Pioneer Crypto Brand in the PhilippinesCoins is the most established crypto brand in The Philippines and has gained the trust of more than 18 million users. Through the easy-to-use mobile app, users can buy and sell a variety of different cryptocurrencies and access a wide range of financial services.Coins is fully regulated by the Bangko Sentral ng...

  • Regional Regulatory Affairs Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand TEOXANE Laboratories Full time ฿1 - ฿2 per year

    Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore...

  • Regional Regulatory Affairs Manager

    2 weeks ago

    Bangkok, Bangkok, Thailand TEOXANE Full time ฿120,000 - ฿240,000 per year

    Date: 26 nov. 2025Lieu: Bangkok, APAC, Thaïlande, 10330Entreprise: teoxanesaTeoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to...

  • Regulatory Reporting

    2 weeks ago

    Bangkok, Bangkok, Thailand KASIKORN LINE Full time

    The Senior Regulatory Reporting is responsible for leading the preparation and submission of regulatory reports to ensure compliance with local standards. This role requires strong coordination across departments, a deep understanding of regulatory frameworks, and the flexibility to support additional tasks beyond core responsibilities.Your RoleLead the...

  • Regulatory Affairs

    2 weeks ago

    Bangkok, Bangkok, Thailand บริษัท วีโก เมดิคอล (ไทยแลนด์) จำกัด (สำนักงานใหญ่) Full time ฿1,200,000 - ฿2,400,000 per year

    Wego Medical (Thailand) Co., Ltd. is engaged in the import, export, and sale of medical equipment, medical devices, spare parts for medical instruments, and other medical-related products. The company is committed to providing high-quality products and solutions to hospitals, clinics, and laboratories across Thailand, while offering reliable customer service...

  • Regulatory Affairs Director

    2 weeks ago

    Bangkok, Bangkok, Thailand PRTR Group Public Company Limited Full time ฿1,200,000 - ฿2,400,000 per year

    More than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people...