Senior Manager, Regulatory CMC
BeiGene
Unknown, Unknown, 日本
Full-Time
Competitive
OfficeManager
About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. To learn more about BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
BeOne 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 the aggressive timelines. The individual will provide support to cross-functional teams on CMC regulatory strategies.
Essential Functions of the Job:
Manages both small molecule and biologics products (Also new modality if applicable).
In collaboration with Global regulatory CMC teams, develop and implement Japan regulatory CMC related submission strategies and timeline; work collaboratively with cross-functional teams and communicate Japan strategies and timeline as needed.
Conduct regulatory risk assessment, lead to identify key regulatory CMC issues and mitigation activities on Japan regulatory submissions.
At CTN stage, receive CMC information from Global regulatory CMC teams and lead the gap analysis per Japan specific CMC requirements. Prepare Japan regulatory CMC related documents.
At NDA/BLA and regulatory maintenance stage, receive core dossier from Global regulatory CMC teams and lead the gap analysis per Japan specific CMC requirements. Prepare Japan CTD M1.2/M2.3 with Global regulatory CMC teams in English/Japanese based on M3 from Global RA CMC team.
Lead to complete local Japan regulatory CMC related forms, proof-reading the translation of the dossier and Health Authority questions, and interpret Health Authority questions.
Provide change control impact assessment on Japan submissions, guide/evaluate judge "PCA" or "MCN" with Global regulatory CMC teams.
Manage manufacturing license including foreign manufacturer accreditation (FMA) for Japan products.
Support Reg CMC interaction with PMDA and supports inspection.
Support the development of Japan CMC dossier template for both CTN and NDA/BLA and contribute to Reg CMC country specific requirement database on Japan requirements.
Support regulatory CMC operational excellence including process establishment or/and optimization.
Support commenting on new/updated Japan CMC related regulatory guidance/regulation through company's commenting process as needed.
Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project in the Japan market.
Supervisory Responsibilities:
The position may manage direct report(s) in the future.
Qualification Required:
BA/BS Degree in scientific disciplines, MS/PhD preferred
Computer Skills:
Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Familiar with Veeva Vault system is plus
Familiar with Japan regulatory system is plus; FD system, Open Trusty/Open Approval system, Gateway system
Other Qualifications:
3+ years of related pharmaceutical or pharmaceutical industry regulatory CMC experience with proven record of experience in market applications and subsequent response to HA (MHLW/PMDA) queries.
Experience in authoring complex technical documents and regulatory CTD (M1.2 and M2.3) sections.
Knowledge of ICH requirements, USP/EP/JP regulatory and requirements.
Knowledge/experience with GMP regulation and post-approval submissions is a plus.
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, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
Travel:
As needed
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
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