• Director, Regulatory Affairs

    BeOne Medicines (Cambridge, MA)


    BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA:

    Job Duties:

    + Provides high level regulatory strategic and operational direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic markets, regulatory strategic development plans and risk assessments, critical issue management and advice on FDA Health Authority interactions.

    + Uses extensive knowledge of US, and ICH regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

    + Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US ensuring timelines are met.

    + Reviews sections of IND, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

    + Liaises and negotiates with FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.

    + Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs.

    + Facilitate policy and development of standard interpretation of global regulation.

    + Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.

    + Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.

    + Manages critical issues, taking leadership for the regulatory contribution.

    + Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture.

     

    Domestic travel to client sites at unanticipated locations across the U.S. may be required 10-20% of the time.

     

    Telecommuting is an option.

    Minimum Requirements:

    + Master’s degree (or its foreign degree equivalent) in Biotechnology, Pharmacology, Toxicology or a related scientific discipline, and eight (8) years of experience in the job offered or in any occupation in related field, OR

    + Bachelor’s degree (or its foreign degree equivalent) in Biotechnology, Pharmacology, Toxicology or a related scientific discipline, and ten (10) years of progressively responsible experience in the job offered or in any occupation in related field.

    Special Skill Requirements:

    + Supporting and preparing IND and NDA applications including responsibility clinical protocol/safety amendments, supplements, and annual reports;

    + Drug development process;

    + FDA regulations;

    + ICH guidelines;

    + Leading cross-functional product development teams. Any suitable combination of education, training and/or experience is acceptable.

     

    Domestic travel to client sites at unanticipated locations across the U.S. is required 10-20% of the time. Telecommuting is an option.

     

    Disregard the below range, the selected candidate will earn a wage of $222,000.00 - $270,000.00 per annum.

     

    Submit resume with references to: Req.#: 24-150829 at: ATTN: Amy Nobriga, [email protected] .

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    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.