Job Overview:
The Associate Director of Global Regulatory Affairs - China will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives in China. This responsibility will include leading client interactions with the NMPA. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactic plans to meet their drug development needs.

Key responsibilities: Collaborate closely with internal Covance project teams in the design and development of regulatory strategies in China for client projects or to answer client inquiries. Collaborate with the Strategic Product Development Consulting group in providing support and input for one another’s projects based on past therapeutic experience and local regulatory expertise. Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by NMPA. Interact and collaborate with all Covance business unit personnel Establish productive working relationship and collaborate closely with Regulatory Submissions staff. Create and build confidence by representing the regulatory strategy function as an informed, capable, knowledgeable, responsible and accessible resource to Covance staff, management and clients, positioning Covance as a preferred source for regulatory strategy expertise. Build successful working relationships with business and scientific leaders across Covance. Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested. Education/Qualifications:
PharmD , MD or PhD in a life science, pharmacy or medicine is required. Experience: Experience within industry (6+ years), experience in Regulatory Strategy (3+ years). Capable of developing relationships with the regulatory agency. Should be acknowledged as knowledgeable in regulatory issues facing pharmaceutical and biotech companies with the ability to translate development strategies into regulatory actions. Capable of establishing credibility with business partners as well as within the company, able to build consensus and achieve goals through influence versus direct line authority. Knowledge of regulatory requirements for the conduct of drug development programs. Knowledge of CMC is a plus. The candidate should have a high degree of integrity, professionalism with the ability to reach out and establish relationships across a global, multicultural organization. Experience of direct interaction with regulatory authorities (e.g. NMPA) through attendance at meetings (t-con and face to face) Background working with multi-disciplinary teams. Excellent planning and organizational skills. Outstanding communication, negotiating, listening and customer service skills with a focus on satisfying customer needs.