Senior/Principal Regulatory Affairs Consultant (China RA Manager)

We are looking for a client dedicated Senior Regulatory Affairs Consultant (China RA Manager). The position can be based in UK or in UE.

Key responsibilities: Lead China regulatory strategy development for R&D portfolio and marketed products LCM for assigned projects Lead CTA & NDA/BLA filings, and CDE consultation preparation activities by working with the China Affiliate and/or CRO, providing supervision to CRO project responsible, to ensure timely Regulatory filings and response to HA queries Represent RA and provide regulatory strategy input to support successful development and provide Regulatory expertise to local product and cross-functional teams Establish strong relationships with key internal and external stakeholders from a local, regional and global perspective. QualificationsSkills and Experience required for the role: University degree required, Life/Health Sciences preferred More than 10 years in drug R&D field 5-8 years regulatory affair experience in a multinational pharmaceutical company (preferably innovator company). In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration. Experience of clinical trial applications and associated strategy Strong leadership capability and ability to work under pressure. Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization. Proficiency in verbal and written English; good computer skill, good presentation skill.