Job Description SummaryThe role shall work with a team of RA experts to manage the RA activities for a region/country. This includes direct responsibility for all local regulatory activities in support of the compliance, registration and promotion of GEHC products in the relevant country. The role works closely with central RA, ASEAN RA lead and local/regional commercial groups. A key responsibility is to maintain strong relationships with the local regulatory authorities & to represent GEHC to key stakeholders.


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Job Description

Responsibilities

In all activities, to work closely with the ASEAN RA LeadTo ensure regulatory compliance for Pharmaceutical Diagnostics (PDx) in the ASEAN regionTo ensure that local RA activities reflect and support both local commercial and global business prioritiesTo drive the development and strengthening of relationships with regulatory authorities and to act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissionsTo provide proactive regulatory advice and expertise to other groupsTo manage the local regulatory activities including;Support to central RA (CRA) for new drug registrations and variationsSupport to local commercial on strategic and operational issues (promotional material, etc.)Support to central Pharmacovigilance for safety issues and adverse event reporting when needed.In cases where there are direct line reports to this position - To manage the recruitment, development, training and activities of internal RA personnel, contractors and consultants. To direct and manage this resource as required to support GE Healthcare business needsTo manage the RA budget for concerned marketsTo actively seek to represent GEHC’s regulatory function outside the company (local congresses and trade association meetings, etc.)To ensure consistent and quality regulatory practices and procedures which are in line with the rest of national RA and meet the needs of CRATo continuously review and put strategies in place to improve existing processes and champion change

Qualifications & Skill set

Bachelor’s Degree in a related field such as Pharmacy, Pharmaceutical Science, Science, Biomedical Science, Biology, Chemistry, Legal Studies, Law, Nursing, Physician AssistanceAt least one year of working experience with good knowledge of ASEAN pharmaceutical drug registration requirements and preferably, Quality Management SystemsExperience in regulatory affairs of pharmaceutical products and in negotiating directly with regulatory authorities, preferably having some experience in ASEAN regulations Strong analytical skillsExcellent verbal, written communication and presentation skillsAbility to prioritize, plan & evaluate deliverablesKnowledge & experience in conducting scientific, regulatory intelligence, legal, or business researchPrior experience using spreadsheet and presentation softwareFamiliar with continuous improvement methodologies such as Lean & Six Sigma

Desired Characteristics

Ability to work across culturesDependability: Being reliable, responsible, dedicated, committed and fulfilling obligationsTeam-oriented and responsive to customer needsAbility to represent the regulatory position effectively to influence internally within the company and externally with regulatory authoritiesAbility to manage regulatory processes to ensure competitive approvals and maintenance of productsAbility to work with minimal supervision on projects and activities

Quality-Specific Goals

Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/positionComplete all planned Quality & Compliance training within the defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredMaintain an up-to-date knowledge and understanding of current regulatory requirements within area of responsibility, including pharmacovigilance requirementsMaintain an understanding of the GEHC SOPs, relevant Pharmacovigilance SOPs, Working Practices and Good Regulatory Practice guide within area of responsibility
 

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Additional Information

Relocation Assistance Provided: No