Senior RA Specialist

• Support the commercial organization and dealers/partners in ASEAN/South Asia to ensure their timely new product launches and sustainable registrations success.
  Manage communications and documentation between Business Units, distributors, regional head office and divisional RA, and manufacturing.
• Ensure that regulatory activities are aligned with commercial priorities, providing necessary insights and guidance to integrate regulatory needs into business strategies.
• Lead timely and regular updates with the commercial, regulatory and management team on any changes in regulations related to pre-market/registration requirements that may have a material impact on the business. 
• Identify any potential issues that may impact the regulatory strategy and timeline for products registrations and develop and propose solutions to mitigate the risk and outcome. 
• Ensure all registration activities meet internal and external deadlines, ensuring alignment with business priorities.
• Manage the product registration projects for all of ASA.
• Support the commercial team on tender and operational issues. 
• Support the development of regulatory strategies for new product launches and market expansions in the region.
• Identify potential regulatory challenges that may impact product registration timelines and propose solutions to mitigate risks.
• Drive continuous improvement in regulatory processes to ensure compliance with the latest regulations and optimize registration efficiency.
• Maintain and develop a Regulatory intelligence database and be capable of analyzing the information available. 
• Monitor and assess changes in local and international regulatory requirements, ensuring that the organization is prepared and compliant with evolving regulations.
• Provide regular updates such as monthly report/tracker to the commercial and leadership teams and any significant regulatory changes or action that may impact the business.
• Maintain records, tracking, master data, monthly reporting and documents related to the ASA region. 
• Provide regulatory expertise and guidance to commercial and cross-functional teams in the region.
• Review, improve, maintain the processes to meet corporate and latest/prevailing regulatory requirements. 
• Any other duties as assigned by the manager 

In addition, the successful candidate will possess:

• A bachelor’s degree in pharmacy, biomedical sciences or related 
• Postgraduate degree as well as regulatory proficiency based on certifications is highly desired. 
• Minimum 5-years’ experience within the medical device or IVDs industry. 
• Proven product registration success track record across multiple product lines. 
• Good knowledge of current global (EU MDD/MDR and IVDR, US FDA) and ASA regulatory requirements. 
• Regional RA experience, with existing experience covering at least 2-3 ASEAN countries 
• Multi-national company experience with specific success working for US or European based companies. 
• Strong analytical and critical thinking skills to interpret complex regulations and determine the appropriate action.
• Strong problem-solving skills and attention to detail.
• Develop and maintain positive relationships with relevant stakeholders.
• Excellent communication skills with ability to effectively interact at all levels as well as cross-cultural awareness. 
• Good oral and written English skill. Proficiency in another Asian language will be advantageous.