SEA Head of Regulatory Affairs

Head of Regulatory Affairs, Southeast Asia

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Overview

For the Abbott Rapid Diagnostics Infectious Disease (ARDx)- we are looking for a talented and dynamic Regulatory professional to lead and manage all related Regulatory Affairs ( RA) activities for the Abbott portfolio in Southeast Asia (SEA) countries (Thailand, Malaysia, Philippines, Singapore, Indonesia, Vietnam, Cambodia, Laos & Myanmar) and manage new product innovation in the region part of the APAC RA regional team.

Responsibilities

• Drive, develop and support regulatory submission plans for the region in collaboration with project team, manufacturing sites, supply chain, marketing, country manager and distributor countries
• Responsible for RA functional report for Southeast Asia countries; Manage the team to ensure timely submission and approval of quality best in class regulatory documentation for pre-market registrations, change notification, or renewal registrations to support product life cycle management as per business needs
• Lead the development and execution of innovative regulatory strategy for New Product Introduction (NPI) in the region; analyze and identify regulatory requirements against project needs.
• Lead, manage and track execution of major regulatory transition in the region to ensure compliance and maintain commercial availability i.e. EU IVDR
• Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal, or amendment to existing product certificates.
• Ensure timely execution of regulatory strategies as per plan.
• Track regulatory milestones in internal Regulatory database.
• Develop, manage, and report regional metrics to track and define Key Performance Indicators for SEA countries.
• Represents RA and/or APAC at relevant meetings.
• Responsible for review of promotional material for assigned geography location.
• Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.
• Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
• Develop and maintain positive relationship with all stakeholders either internal or external including key opinion leaders and key influencers in regulatory bodies & industry associations while building Abbott Rapid Diagnostics credibility and trust.
• Attract, develop and retain a high performing regulatory organization while developing a strong talent and leadership pipeline capable of delivering regulatory success in a changing market environment.

Reporting to

• APAC RA Head ARDx (solid)
• General Manager, SEA region (dotted)

Qualifications

• Bachelor or higher degree in Biomedical/Medical Sciences, Pharmacy, Engineering or other Life Sciences.
• A minimum of 7 years’ experience in Regulatory Affairs in Medical Devices, preferably in IVDs

Competencies and Attributes

• Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD)
• Demonstrated capacity in project management.
• Able to navigate in a cross functional environment.
• Knowledge of the APAC regulatory environment (ASEAN, SAARC countries), including SaMD, US FDA, AMDD, IVDR (EU 2017/746), IMDRF and regional digital health regulations and requirements, legislation, industry standards and guidance.
• Excellent written and oral communication skills in English and an ability to influence, lead, negotiate and work effectively at all levels.
• Attention to detail.
• Strong interpersonal skills.
• Highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality internally and externally.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.