RA Manager/研发合规经理

面议

上海市硕士及以上

刷新时间：2020-08-11

职位描述

Summary of Job:
The Regulatory Affairs – CMC RA Manager independently manages all regulatory CMC aspects of assigned products throughout their lifecycle. This includes Biologics, Small Molecule, and Drug/Device combinations. The CMC-RA Manager is responsible for the regulatory CMC strategy of submissions for all products and handle registration sample testing under his/her responsibility. Has sound understanding and experience in navigating China regulatory environment as well as managing interactions with China regulatory authorities on CMC issues.
CMC RA Manager leads the CMC communications with the authority CMC reviewers/IDC official and KKC/KKAP CMC experts for an efficient strategic decision making, risk evaluation, risk mitigation and issue resolution.

Essential Functions:
• Support the development and creation of global regulatory CMC strategies for multiple clinical development projects at all stages relevant to APAC or China (Phase I through post-approval), with a focus on innovation, maximizing the business benefit balanced with regulatory compliance.
• Participate in all CMC related regulatory submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products throughout their lifecycleAdvise or make quality regulatory decisions, balancing risks and benefits.
• Plan, prepare, and critically review CMC components of regulatory documents including INDs, variations, NDAs, re-registration, DMFs, Meeting Briefing Packages,Meeting Records IBs, Annual Reports/DSURs, and equivalent documents. Collaborate with project team representatives to ensure those documents meet regulatory requirements/guidance.
• Align with the manufacturing site and Global CMC to respond in a timely manner to CMC related questions and inquiries from health authorities.
• Lead the preparation for, and conduct of, formal CMC meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
• Provide regulatory CMC input for change controls and support change implementation and variations applications strategically.
• Communicate risks along with mitigation strategies to the global project teams and regulatory steering committee.
• Gather up-to-date regional regulatory CMC information from available resources such as industrial committees, conferences, and literature and provide as regulatory intelligence. Respond to authority notifications for public comments on behalf of the Company.

Job Requirements:
Education
• 6+ years pharmaceutical industry and 2+ relevant regulatory CMC experience, experience specific to APAC is preferred.
• Bachelor’s degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, Pharm D, MD) is preferred.

Technical Skills
• Ability to conduct critical evaluations of analytical data and set quality specifications.
• Expert knowledge of the fundamental principles of pharmaceutical drug substance/drug product CMC development.
• Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to both chemical and biological CMC.
• Experience with authoring of the drug substance and drug product sections.
• Prior experience with authoring, submission, and approval process of a major marketing application
• Prior experience in leading the technical communications with China CDE CMC reviewers.



Non-Technical Skills
• Cultural sensitivity is essential and the ability to develop consensus within a multinational organization.

• Ability to proactively identify issues, develop mitigation strategies, and successfully negotiate its delivery with key stakeholders.
• Ability to supervise and coach regulatory colleagues as needed.
• Good communication skill among internal and external related key stakeholders

Language Skills
• Excellent English written and oral communication skills.

Working Conditions:
This position may require up to 10- 15% business travel.

其他要求

招聘人数：1人
汇报对象：RA Director
职能类别：法务合规经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。