Are you an experienced regulatory affairs professional with strategic experience of new product registration in China?
Vifor Pharma has a newly created opportunity for a Regulatory Affairs Director based in Beijing, China to lead the regulatory function in the local affiliate and drive strategies to accelerate regulatory approval for our product portfolio in China.
Manage, guide and develop the local RA team, ensure planned local regulatory affairs activities are delivered in time and proper local Regulatory procedures and policies are in place.
Support Global Regulatory Affairs in accelerating the approval of Vifor portfolio in as a key RA SME for specific considerations related to regulatory frameworks in China.
Act as RA lead to develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc) in China
Develop and evaluate registrations as well as clinical strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels.
Act as key regulatory affairs subject matter expert for specific considerations related to relevant strategic objectives regarding Advocacy, functional capabilities, and clinical design strategies.
Proactively address industry trends and opportunities, and key regulatory trends related to registration requirements, clinical development and clinical requirements supporting new product approval.
Act as primary Vifor RA representative in front of the CDE in collaboration with Global RA International Strategy group.
Provide input for GRA International Strategy in interpreting public information related to approval of products and on conditions for building regulatory dossiers to support the safety, efficacy, medical usefulness, and marketability of drug and product candidates in China.
Review and ensure that the design and conduct of clinical development programs and individual studies are appropriate to generate data supportive of registration in China.
Advanced degree in pharmaceutical or health related field
At least 10-12 years’ experience with regulatory affairs in the pharmaceutical industry (prescription drugs) in China
Demonstrated experience managing regulatory strategy and submission of dossiers including study design, data review, approval strategies and labelling negotiations in China
Demonstrated experience interacting with local health authority bodies and local health experts
Solid knowledge of the Chinese regulatory environment, clinical practice regulations in China
Proficiency in Mandarin and English (verbal and written) is essential
Experience in pharmacovigilance regulations is a plus
Experience in anaemia, nephrology, rare diseases or speciality drug development is preferred