Associate Director, Regulatory CMC (大分子)

General Description: Reg CMC Large molecule (Biologics) position. Be responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives. Manages regulatory CMC aspects of compounds through all phases of development, post-approval and life-cycle of the product depending on assigned products. Applies regulatory & relevant technical knowledge to identify & mitigate potential regulatory issues. Located in Shanghai/Beijing/Guangzhou. Essential Functions of the job: Serve as the regulatory CMC representative in the 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 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 regulatory CMC timelines in cooperation with Project Management for the 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 Education Required: Educational background in scientific disciplines and expertise in at least one area in biologics CMC development (chemical process, formulation, manufacturing, QC, QA, etc.) Computer Skills: Strong PC literacy required; Microsoft 360 skills (Outlook, Word, Excel, PowerPoint) Other Qualifications: Minimum 5 years of experience in Regulatory CMC related position with expertise in biologics and deep experience in commercial product lifecycle as well as Phase 1- 3. Educational background: BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred. Experience in authoring complex technical documents or regulatory CMC related submissions. A good understanding or IND, CTA, BLA and MAA processes. In-depth knowledge of ICH requirements, China, and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for ROW regions and GMP regulation is a plus. Excellent oral and written communications skills are a must-have. Familiar with Veeva system is a plus. The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial and fast-paced environment. Strong negotiating skills and ability to think creatively and develop creative solutions. Ability to prioritize and handle multiple projects simultaneously. 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