描述

Primary Job Function

• To manage the regulatory aspects of Core Diagnostics NPIs and on-market products updates to comply with local Government Regulatory and Statutory legislation in alignment with department goals.
• To liaise with internal and external stakeholders.
• Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
• To ensure all Core Diagnostics Departments are in compliance with the local regulatory requirements, specific to importation and supply of products to the local market.

Core Job Responsibilities

Regulatory

• Focus on Regulatory, Registration and Reimbursement strategies for new and currently registered products. Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory outcomes to support Marketing goals.
• Focus on ensuring all products requiring local clinical/performance evaluations, at various local institutions, including designated testing laboratories and hospitals, are done and completed within the timelines required for NPI launches or renewals, ensuring no disruption to commercialization.
• Maintain necessary contacts with all Regulatory and Statutory bodies, government representatives and industry associations.
• Partnering with local regulatory agencies and industry associations on new and changing regulations in the country.
• Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
• Be the key liaison point for all regulatory enquires across the organisation.
• Support all aspects of auditing and accreditation requests.
• Support, and assist by providing the regulatory specific documentations required for Commercial Tenders.
• Ensure all reportable serious or adverse incidents are filed in a timely manner, according to local regulatory requirements.
• Review and approval of Promotional Materials in compliance with regulatory requirements.
• Manage and Maintain appropriate Licenses and Import/Export permits.
• On a timely basis, prepare or arrange for preparation, the Regulatory budgets, reports and forecasts.

Supervisory/Management Responsibilities

• Effective management of the Company's regulatory affairs change strategy
• To work in a collaborative environment with functional departments, i.e. Marketing, Logistics etc. to ensure regulatory compliance with regulations and other relevant Regulatory Agencies.
• Ensure that RA team members are skilled and kept up to date with changes to regulations and standards and to advise local and global colleagues of the impacts of such changes.

Position Accountability / Scope

• Reporting to APAC RA Associate Director
• Responsible for maintaining RA Department and submissions budget

Minimum Education

• Bachelor Science degree
• Detailed knowledge of various regulatory agencies in country

Minimum Experience/Training Required

• Minimum 7 years regulatory experience within the diagnostics industry
• Working experience in regulatory agency is a plus

Minimum Skills Required

• Proven ability to lead a team
• Influence Skills