We are a leading chemical company, with the best teams developing intelligent solutions for our customers and for a sustainable future. Our success as a company relies on the engagement of our employees. We encourage our employees to develop their strengths, and we recognize their achievements. For you, this means a wide variety of job roles, and exciting opportunities for learning and career development.
BASF has been a committed partner to Greater China since 1885. With large production sites in Shanghai, Nanjing and Chongqing, BASF is a major foreign investor in the country’s chemical industry, and operates the Innovation Campus Shanghai, a global and regional research and development hub. BASF posted sales of over €7.3 billion in 2019 to customers in Greater China and employed 9,230 people as of the end of that year. For further information, please visit www.basf.com/cn/en
· Ensure regulatory compliance, achieving and maintaining the registration of pharmaceutical active ingredients and excipients in China through the application of entrepreneurial principles. For this task, this person is in close cooperation with the local sales team, global business management team and global regulatory team.
· To proceed and maintain product registration to support business compliance.
· To provide regulatory updates and advice to sales team to support development of business unit.
· To meet customers’ regulatory requests to develop business.
· To keep professional & effective communication with global team and the authority.
· Key person in ensuring the regulatory compliance of the pharma product portfolio in China taking responsibility for product registrations and maintenance.
· Routinely support sales team on regulatory topics and proceed relevant customer inquiries.
· Cooperate with global team on regulatory issues/ projects and coordinate communication with sales team, global business management team, external parties and end customers.
· Work closely with technical team in terms of specification set up & analytical method related topic.
· Actively monitor regulatory updates and give analysis/ recommendations to country/regional/global team.
· Monitor excipient regulations by working with industry associations the relevant govt dept & agencies for special projects/ products.
· Regularly report to supervisor to enable strategic decision making on existing and pipeline products.
· Bachelor above degree, major in Pharmacy/ Medical Science /Chemistry.
· No less than 2~ year experience of regulatory affairs in pharmaceutical / medical industry.
· Fluent oral & written English.
· Solid experience and knowledge of pharmaceutical related regulation, working procedure in the industry.