北京招聘

Reporting to the global VP of Regulatory Strategy and General Manager of Covance China, this senior position will serve as the primary point of contact for all China related regulatory affairs for internal teams and external clients. This position will work across various Covance China business units as well as the global teams to facilitate dialogues with our clients to develop relevant regulatory strategy and tactic plans to meet their drug development needs in China. This position will also serve as the most senior leader in China for the various regulatory functional staff in a matrix environment.

Key responsibilities:
? Provide the leadership and strategic direction for the regulatory affairs activities across all Covance business units in China.
? Collaborate closely with internal project teams and the Global Regulatory Team in the design and development of regulatory strategies for client projects or to answer client inquiries.
? Collaborate closely with Covance Regulatory Strategy staff in developing global regulatory strategies for clients.
? Collaborate closely with local Regulatory Submissions staff and provide mentoring and guidance as required.
? Work closely with sponsor companies and internal teams in the organization and preparation of clear and effective submissions.
? Engage in proactive relationships with the SFDA to build and sustain an outstanding ongoing association.
? Maintain knowledge of the regulatory environment by reviewing and implementing current policies/practices issued by the SFDA.
? Create and build confidence by establishing the regulatory strategy function in China as an informed, capable, knowledgeable and accessible resource to staff, management and sponsor companies, positioning Covance as a preferred source for regulatory expertise in China.
? 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.
? Act as a spokes person for the regulatory function in China and represent Covance China on in-country regulatory affairs related matters through participation in industry meetings and symposia.
? Establish strong partnerships with global/regional function leaders to provide in-country advice to support staff development.




Position Requirements:
? The ideal candidate will possess 10+ years experience with increasing levels of responsibility in regulatory affairs leadership roles and a track record of successful drug submissions and approvals in China.
? A successful track record of developing relationships with the SFDA.
? Should be acknowledged as an expert in China for regulatory issues facing pharmaceutical and biotech companies with the ability to translate development strategies into regulatory actions.
? Capable of establishing immediate credibility with business partners as well as within the company, able to build consensus and achieve goals through influence versus direct line authority.
? Thorough knowledge of regulatory requirements from China SFDA for the conduct of drug development programs.
? The candidate should have a high degree of integrity, professionalism with the ability to reach out and establish relationships across a global, multicultural organization.
? Background working with multi-disciplinary teams and experience in all phases of drug development.
? Outstanding communication, negotiating, listening and customer service skills with a focus on satisfying customer needs.
? Strong command of the English language.
? An advanced degree with a focus in the sciences is required, an MD or PhD is preferred.

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/