• Associate Director, Regulatory CMC (Small…

    BeOne Medicines (San Mateo, CA)


    _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 and HA interactions to meet the aggressive timelines for the assigned projects. The individual will provide support to cross-functional teams on

     

    CMC regulatory strategies and process optimizations on relevant topics.

    Essential Functions of the job:

    + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications.

    + Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project

    + Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects.

    + Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely.

    + Lead or contribute to development of internal small molecule CMC regulatory guidance and working

    + instructions.

    + Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project.

    + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project.

    + Provide comments on new global guidance through company’s commenting process.

    Supervisory Responsibilities:

    The position may or may not manage direct report(s).

    Computer Skills:

    Microsoft 360, Familiarity with Veeva is a plus.

    Qualifications:

    + 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.

    + EducationRequired:BA/BSDegreeinscientificdisciplines,MS/PhDpreferred.

    + A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries.

    + In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.

    + Demonstrated leadership as a people manager.

    + Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management.

    + 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.

     

    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.