Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
The JAPAC RA Operations Senior Specialist plays a key role in enabling effective and compliant regulatory operations across the JAPAC region. This position is responsible for driving process excellence, supporting regional regulatory execution, and partnering with cross‑functional and in‑country RA teams to ensure timely, high‑quality regulatory outcomes that support business objectives.
How you’ll make an impact:
Lead and continuously improve JAPAC Regulatory Affairs operational processes through process optimization initiatives, digitalization, and the adoption of AI‑enabled solutions to enhance efficiency and scalability.Execute and support regional regulatory operations processes, including close collaboration with cross‑functional stakeholders and in‑country RA teams to obtain regulatory information and maintain accurate, compliant records within regulatory databases.Track regulatory timelines and document key milestone achievements to support management decision‑making, regulatory strategy development, and prioritization of submissions in alignment with operating plans and country/regional objectives.Provide timely and accurate regulatory updates to relevant stakeholders, ensuring transparency, alignment, and proactive issue management across the region.Monitor regional regulatory changes in collaboration with the Regulatory Intelligence function and in‑country RA teams; support the assessment, planning, and execution of required actions to ensure compliance while minimizing business impact.Own and manage JAPAC RA Standard Operating Procedures (SOPs), coordinating with in‑country RA teams to ensure documents are current, compliant, and consistently applied across the region.Actively contribute to process improvement and remediation initiatives to accelerate new product launches and improve responsiveness to requests from regional and international affiliates.Provide operational and project support to the supervisor and regional RA leadership team as needed.
What you'll need (Required):
Bachelor’s degree with 3–5 years of experience in the medical device, biotechnology, or pharmaceutical industry, preferably within Regulatory Affairs or a regulated environment.Demonstrated knowledge of good documentation practices, with a strong ability to maintain accurate, high‑quality regulatory records.What else we look for (Preferred):
Strong organizational, analytical, problem‑solving, and critical‑thinking skills, with the ability to manage multiple priorities in a fast‑paced environment.Excellent written and verbal communication skills in English; additional languages (e.g., Korean) are an advantage.Highly detail‑oriented, well‑organized, and methodical, with a proactive mindset and the ability to work effectively in a collaborative, cross‑functional team environment.Ability to influence change and drive process improvements through effective collaboration with management and functional stakeholders, without direct authority.Ability to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, pro-active attitude to provide suggestions to management.