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.
Senior RA Specialist