Posted in Information Technology about 2 hours ago.
Type: Full Time
Location: Cambridge, Massachusetts
Job Description
About this role
As Regulatory CMC Small Molecules Team Lead you are responsible for the line management of direct reports, with responsibilities for the small molecule portfolio. The Regulatory CMC Team Lead with the Regulatory CMC Global Regulatory Lead (RegCMC GRL), where applicable, assigns activities to the team members, supports the team members in setting regulatory CMC strategies and their daily work. Where a program does not have a designated RegCMC GRL you provide regulatory strategic support and advice for the program when required. You ensure coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities. In this role you are responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals of clinical trial applications, initial marketing authorization applications and lifecycle changes with a focus on small molecule programs, 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
What we offer
A leadership role where you are able to work with accountability, both independently and within project teams or committees to attain group goals and key project milestones. Inclusive leadership, strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
Qualifications
Regulatory Skills
Leadership/Management Skills
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
PDN-9ce90844-b0f8-4762-989d-4468dbf34227
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