clinical regulatory affairs

Job Description: Responsible for US Regulatory Affairs

Job Responsibilities:

• Formulate, lead and drive regulatory strategy for chemical and biological modalities to support clinical development in oncology and autoimmune disease areas from early development throughout product registration in the US and other countries

• Lead and drive Regulatory submission activities (planning, authoring, reviewing, coordination, submission) in support of Pre-IND, IND, NDA/BLA and other product life-cycle activities and Health Authority consultations

• Responsible for delivering high quality Regulatory dossier or other submission documents

• Lead Health Authority interactions for product development, including setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans

• Become an integral part of the broader team in planning of regulatory activities and implementing regulatory strategies

• Ensure Regulatory planning and activities to be in line with overall program strategies and timelines; present and defend Regulatory strategies in crossfunctional project team meetings with partners and stakeholders

• Collaborate with other functions to ensure Regulatory compliance and auditing/inspection

• Maintain expert knowledge in Regulatory guidance/guideline and competitive landscape in company product development

• Support other regulatory and/or program needs as needed

Qualifications and requirements:

• Science degree (e.g. Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy) or equivalent; advanced degree desired

• Minimum of 5 years’ experience in Regulatory Affairs and pharmaceutical clinical development; preferred experiences in oncology an autoimmune therapeutic areas

• Extensive knowledge in FDA, EMA and ICH guidance/guidelines and expertise in regulatory submission and approval processes; ability to analyze complex regulatory issues and requirements

• Demonstrated successful experience in delivering Regulatory milestones in product development and registrations

• Experience of direct communications and negotiations with Regulatory agencies

• Demonstrated competence in leading functional team to support Regulatory activities and interface with CRO in related tasks • Meticulous attention to detail and ability to follow procedures

• Candidate must be highly organized and capable of working independently in a team environment with a positive attitude

• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality

• Must be able to discern the criticality of issues and communicate to management regarding complex issues

• Ability to manage conflict and issues that arise with internal team and external customers/partners

• Strong sense of overall program success and flexible in providing support

• Excellent written/spoken communication skills in English; understanding Mandarin a plus

• Flexible with working hours with some night TC with team and corporate office in China