About This Role

This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule, 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.

What You’ll Do

• Accountable for strategy, planning, definition of content, preparation, review and approval of global CMC regulatory submissions and responses to Health Authority questions.
• Ensure that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
• 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.
• Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
• Highlight and proactively communicates anticipated and ongoing critical CMC regulatory issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
• Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
• Participate in skill development and coaching of other Global RegCMC Team members as required.
• Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
• Responsible for management, coaching and development of direct reports as applicable.

Who You Are

You are an a technical expert, passionate about leading and driving regulatory CMC strategies, owning clinical trial programs and team work oriented.

Required Skills

• BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
• At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Clinical Regulatory CMC (ideally on Phase II & Phase III) and 2 years professional experience in pharmaceutical manufacturing for small molecules.
• Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new 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 CMC topics
• Knowledge of global guidance, regulations and ICH/GMP requirements
• Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
• Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
• Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
• Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.

This is a dual role of the CMC GRL and the CMC Regional Regulatory Lead (CMC RRL) in the region in which the CMC GRL is located.  In addition to the accountabilities and responsibilities presented, the CMC GRL also assumes the role and responsibilities of the CMC Regional Regulatory Lead (CMC RRL) for assigned projects/products in the region in which the CMC GRL is located.

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.