Regulatory CMC Small Molecules Team Lead

17 hours ago

Cambridge, Massachusetts, United States Biogen Full time
Job Summary

We are seeking a highly experienced Regulatory CMC Team Lead to lead our small molecule portfolio. As a key member of our Regulatory CMC team, you will be responsible for the line management of direct reports, defining regulatory CMC strategy, and planning and preparing global CMC regulatory submissions.

Key Responsibilities
  • Accountable for line management and development of direct reports.
  • Define regulatory CMC strategy and plan and prepare global CMC regulatory submissions.
  • Lead the development of working processes and activities to increase efficiency within the RegCMC function.
  • Accountable for strategy, planning, definition of content, preparation, review, and approval of RegCMC submissions and responses to Health Authority questions.
  • Highlight and proactively communicate anticipated and ongoing critical RegCMC issues throughout the product lifecycle.
Requirements
  • BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
  • At least 10 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for new oligonucleotide, and/or complex 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.
What We Offer

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.

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