General Description:BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies.Essential Functions of the job:
Develop and implement small molecule regulatory CMC strategies as well as author CTD CMC sections for assigned projects to ensure on-time and high-quality global submissions for investigational, marketing, and post-approval applications.
Develop regulatory strategy and execute the preparation of timely responses to small molecule regulatory CMC questions, pre-meeting packages, and interactions with Heath Authorities as needed for assigned projects.
Work collaboratively with cross-functional leads and communicate regulatory CMC strategies for assigned projects.
Lead regulatory risk assessment, identify key regulatory CMC issues and mitigation activities needed throughout product life cycle. Escalate critical issues to senior management.
Lead or contribute to development of internal regulatory CMC guidance, SOPs, and work instructions.
Ensure proper regulatory CMC assessments and actions are taken when recalls or product complaints arise during product lifecycle for assigned projects.
Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for assigned projects.
Provide comments on new global guidance through company’s commenting process.
Computer Skills: Microsoft 360Other Qualifications:
7+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience with proven record of experience in global submissions for clinical trial/marketing applications and subsequent response to HA queries.
BA/BS degree in scientific discipline, MS/PhD preferred.
In-depth knowledge of ICH requirements and US/EU regulatory requirements.
Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus. Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections.
Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.).
Excellent oral and written communications skills are a must-have.
The candidate should be detail-oriented, self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
Travel: 0-5%All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
