Jobs for People with MS: National MS Society

Senior RA Specialist

Singapore

• 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.