Biogen Head CMC Global Regulatory Lead, Devices and Combination Products in Cambridge, Massachusetts
Who You Are This candidate must have proven leadership and abilities to work cross-functionally and across cultures, has strong communication, regulatory CMC knowledge and interpersonal skills. What You’ll Do * Oversee and lead device / combination product related strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions. * Ensures that the global regulatory CMC combination product / device strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements. * Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines. * Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products. * Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams. * Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate. * Facilitates capture and communication (within and outside of Global RegCMC) of CMC lessons learned from major submissions for assigned projects/products. * Accountable for regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions, as it pertains to device/combination product related topics. * Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products. * Partners with regulatory regional leads for exchange of project/product related information and submission planning. * Accountable for the coordination and overall global approval of regulatory assessments for CMC changes. * Monitors and influences changes in the global Regulatorily CMC environment in alignment with business needs. * Defines and communicates the need for internal and/or external regulatory CMC resource to the Global RegCMC Leadership Team as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines. * Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located. * Represents Global RegCMC-devices/combo product on due diligence and divestment teams as assigned by the Global RegCMC LT. * Leads or provides input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT. * Participates in skill development and coaching of other Global RegCMC Team members * Responsible for management, coaching and development of direct reports Required Skills * BS degree (Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science is preferred), plus a minimum of 10 years relevant experience (pharmaceutical industry or a regulatory authority CMC review capacity is preferred). * Professional experience in combination product development and/or lifecycle management also highly desired. * Successful leadership in delivering device / combination product related CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities * Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions. * Extensive experience of direct communication and negotiation with regulatory agencies on combination product specific topics * Knowledge of global guidance, regulations and ICH/GMP requirements * Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure * Experience in people management. Leadership within a cross functional, matrix organizational structure may also be considered. Preferred Skills Graduate degree preferred This role is responsible for defining regulatory device / combination product CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development and/or commercial programs. Responsibilities include; actively leading the development and implementation of global CMC regulatory strategy for specific devices and combination products, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program. This role will also manage a growing team. Responsibilities will include coaching and mentoring, managing priorities and work load and setting a strategic direction for the portfolio they oversee.