What You’ll Do

• Accountable for devices / combination products related strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions. 
• Identify supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
• Highlight and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
• 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.
• Partner with regulatory regional leads for exchange of project/product related information and submission planning.
• Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
• Represent Global RegCMC-devices/combo product on due diligence and divestment teams as assigned by the Global RegCMC LT.
• Lead or provide input to Global RegCMC initiatives and cross functional work streams as assigned by Global RegCMC LT.

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.

Qualifications

Required Skills

• BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science is preferred plus a minimum of 10 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity
• 5+ years of experience in Regulatory CMC and preferably 2 years professional experience in combination product development and/or lifecycle management
• 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

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 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.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

The base compensation range for this role is $130,900 to $218,100. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.