• 招聘类型：社招
• 工作性质：全职

职位描述

• Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
• Manage interactions with CFDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
• Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and is able to interpret and apply local regulations and guidance’s to the life cycle of a drug product.
• Manage/prepare CMC document packages for regulatory submissions in support of development programs. This includes initial submission of INDs, CTAs and amendments to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
• Manage timelines in cooperation with Project Management on assigned projects.
• Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with regulatory requirements, strategies and commitments.
• Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide strategic regulatory guidance for optimal implementation of changes.
• Actively participate as a member of global regulatory teams and CMC subteams.
• Support and manages regulatory aspects of CMC Operations including authoring, reviewing and and/or approving SOP’s, CAPA’s, etc.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
• Other duties as assigned

Core Competencies, Knowledge and Skill Requirements

• Expertise in commercial product lifecycle as well as Phase 1-3.
• Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experience desired.
• A good understanding or IND, CTA, BLA and MAA processes.
• Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
• Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
• Demonstrated ability to coach, train and mentor teams.
• Strong negotiating skills and ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.

Communication & Interpersonal Skills

• Excellent interpersonal, oral and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.
• Proven ability to build trust and respect within the organization

Significant Contacts

• Interacts with BeiGene employees and senior management.
• Interacts with external business partners and Regulatory Agencies.

任职条件

REQUIREMENTS:

BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred.

Experience

Minimum 10 years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in commercial product lifecycle as well as Phase 1-3.

职位要求

• 学历要求：本科及以上
• 工作经验：2年以上
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日