Senior Specialist, Regulatory Affairs

Description

• 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.

Qualifications

• 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.