Regulatory Affairs Specialist, ASEAN

Job Description Summary

The 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 Lead
• To ensure regulatory compliance for Pharmaceutical Diagnostics (PDx) in the ASEAN region
• To ensure that local RA activities reflect and support both local commercial and global business priorities
• To 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 submissions
• To provide proactive regulatory advice and expertise to other groups
• To manage the local regulatory activities including;

• Support to central RA (CRA) for new drug registrations and variations
• Support 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 needs
• To manage the RA budget for concerned markets

• To 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 CRA
• To 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 Assistance
• At least one year of working experience with good knowledge of ASEAN pharmaceutical drug registration requirements and preferably, Quality Management Systems
• Experience in regulatory affairs of pharmaceutical products and in negotiating directly with regulatory authorities, preferably having some experience in ASEAN regulations Strong analytical skills
• Excellent verbal, written communication and presentation skills
• Ability to prioritize, plan & evaluate deliverables
• Knowledge & experience in conducting scientific, regulatory intelligence, legal, or business research
• Prior experience using spreadsheet and presentation software
• Familiar with continuous improvement methodologies such as Lean & Six Sigma

Desired Characteristics

• Ability to work across cultures
• Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
• Team-oriented and responsive to customer needs
• Ability to represent the regulatory position effectively to influence internally within the company and externally with regulatory authorities
• Ability to manage regulatory processes to ensure competitive approvals and maintenance of products
• Ability 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/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Maintain an up-to-date knowledge and understanding of current regulatory requirements within area of responsibility, including pharmacovigilance requirements
• Maintain 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