Senior Regulatory Affairs Specialist

Provide management team with regular updates on product registration and new regulations from government body. Provides input on regulatory-related issues associated with compliance and achieving the business plan. Prioritize and plan on product registration for his/her respective product lines. Preparing, coordinating and submitting regulatory applications to the local health authority. Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration. Ensure product registrations are reviewed for change notifications and renewed as required. Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education. Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs. Supports tender operations by timely supply of accurate regulatory documents. Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies. Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation. Serves as regulatory consultant to commercial team and internal stakeholders. Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy. Bachelor's degree in Pharmacy, and must be a registered Pharmacist. Minimum 5-years of working experience in regulatory affairs within medical device industry. Strong in-depth conceptual, practical, technical, and/or functional knowledge of principles and theories in local country regulatory policies. Able to work independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems. Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges. Critical thinker with good problem-solving skills. Minimum intermediate level in MS Office skill.