南京招聘

Business Segment

Healthcare Life Sciences

About Us

N/A

Role Summary/Purpose

The Greater China RA Director is a key and highly visible role responsible for setting the National Product Strategy in partnership with the Segment RA Lead, national business priorities and local regulatory requirements. The National lead will be National Champion for regulatory compliance in the assigned county. The role will report to AP RA Head of RA in the Life Sciences CTO function.

Essential Responsibilities

• To ensure the assigned country proactively develops effective regulatory strategies and operational plans that meet business goals in an effective, timely and compliant manner.
• Drive the implementation of the aligned targeted goals in the assigned National RA (NRA)
• Form and build/maintain talent in the NRAs that will enable effective strategic regulatory access locally
• Ensure that highly effective proactive strategic input is provided to the global Regulatory plans that will enable competitive and timely patient access for the markets in the assigned region
• Be the SME (Subject Matter Expert) on local country requirements for the assigned NRAs within RA
• Lead and manage the NRA team in the assigned country through exemplary leadership behaviors including effective decision making and ownership of RA matters in the assigned NRAs and ensuring budget targets for the assigned country.
• To identify and assess risk and mitigation solutions and recommendations on product/project issues even under conditions of uncertainty.
• To effectively manage regulatory processes to ensure competitive approvals and maintenance of products.
• To ensure consistent and quality regulatory practices and compliance for all GEHC products in the assigned country and that all Regulatory Affairs activities reflect both local commercial and global business priorities.
• To contribute strategically to the business. To provide proactive regulatory advice and expertise to other groups on a global basis.
• To be the main point of contact with CFDA on behalf of Core Imaging GEHC and act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions, including developing and strengthening relationships with local regulatory authorities.
• To monitor the external environment, with a view to influencing changes to the benefit of the business and adapting regulatory strategies proactively. To develop and implement complex influencing and negotiating strategies which demonstrate political awareness
• To direct activities and manage the human and financial resources required providing regulatory input into project/product teams in accordance with business needs.
• To provide guidance, management and accountability for ensuring that systems, process and procedures are developed, implemented and maintained to lead efficient working practices across the groups.
• To take responsibility for the recruitment of effective talent, development and training of department members in line with business needs.
• To lead and develop an effective team of internal and external regulatory professionals as well as cross-functional teams.
• To liaise with heads of Quality Assurance, Pharmacovigilance, Medical Affairs and Central Regulatory Affairs to ensure these cross-functional groups receive the support as agreed.
• To deputise for the AP head of Regulatory Affairs (Regulatory Affairs Executive) as required.

Qualifications/Requirements

• Advanced degree in a Science discipline. Minimum 10 years’ experience in Regulatory Affairs within the pharmaceutical industry or minimum of 5 years regulatory affairs management experience. A considerable amount of this experience should have been gained in a senior role in the area relevant to their position
• Demonstrated experience interfacing with China CFDA is a must (and with Taiwan TFDA and HK DoH a plus), including negotiation of pharmaceutical product approvals & lifecycle maintenance, resolution of issues and influencing/lobbying directly and through other external groups (e.g. trade associations)
• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies in Greater China would be highly desirable.
• Ability to work independently as required using sound judgment
• Demonstrated ability to form, lead and manage cross-functional, cross-business teams.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Demonstrated project management skills to plan and deliver on established tactical and strategic goals
• Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
• Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements. Knowledge of languages in the assigned NRAs will be advantageous.
• Ability to influence and make recommendations at all levels of the company
• Must be willing to travel as needed for key activities.

Desired Characteristics

• 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. Training will be provided where appropriate.
• 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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