Commercial Regulatory Head Apac

2 weeks ago

Central Singapore Abbott Laboratories Full time
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

RESPONSIBILITIES:

  • Acts as a Strategic partner and contributor to the APAC leadership team ensuring that all regulatory aspects and local RA team support the growth and sustainability of ARDx products in the region.
  • Ensure that the Regulatory goals and objectives of the region are aligned with the Commercial needs and organizational goals.
  • Oversee the Regulatory Activities of the region, identify risk at an early stage, develop mitigation plans and communicate to relevant stakeholder in a timely manner.
  • Manage the APAC regulatory team in the development and implementation of Regulatory strategies at Affiliate and distributor level, in collaboration with manufacturing sites and regional functions for New Product Introduction, GeoExpansion and changes to existing products.
  • Support localization initiatives in the Region in partnership with local site and Abbott manufacturing sites.
  • Build, manage, develop and maintain a high performing RA team at local and regional level.
  • Lead process improvement initiatives to develop efficiencies in the RA team.
  • Introduce and track KPI to measure team performance and timely execution of product registration and critical changes as per business needs.
  • Represent Abbott and build strong connections in external regulatory forum with regulators and industry association.
  • Actively monitors the regulatory environment to ensure continued compliance and ensure efficient communication thereof.
  • Ensures efficient review of advertising and promotional material and/or publicly disseminated information for compliance with country specific requirements.
  • Supports the Legal manufacturer in the reporting of complaints, adverse events and FSCA/FSN notifications to the Regulatory Authorities in the respective countries as applicable to regulations.
  • Promote awareness of regulatory and customer requirements throughout the organisation.
  • Represent RA APAC at leadership meetings.
  • Actively participates in short and longrange planning.
  • Upholds the company's core values.

QUALIFICATIONS & EXPERIENCE:

  • Bachelor's Degree in science, engineering, medical/biomedical or other science related field.
  • 10 years of experience in Regulatory Affairs in Medical Devices in APAC.
  • 5 years' experience in people management.
  • Strong knowledge and experience of the IVD regulatory frameworks and policies in the region.
  • Experience in working in a multifunction team environment and managing multiple countries/markets with diverse environment.

COMPETENCIES:

  • Proven track records of successful IVD registrations in China, South Korea and India.
  • Strong analytical, problem solving, communication, decisionmaking and leadership skills.
  • Capable of managing complexity across the business to consistently deliver expectations while meeting internal and external requirements.
  • Able to identify and anticipate risks at an early stage to identify solutions in a timely manner.
  • Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.
  • Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work effectively within a team in a fastpaced changing environment. Multitasks, prioritizes and meets deadlines in timely manner.


Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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