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RegCMC Small Molecules Team Lead

2 months ago

Cambridge, United States Biogen Full time
Job DescriptionJob DescriptionJob 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

 

  • Accountable for line management and development of direct reports.
  • Managing RegCMC small molecule resources efficiently – budget tracking, ensure proper resources allocation (including external regulatory partnerships), enhance knowledge sharing and support the team to prioritize activities.
  • As part of RegCMC, lead the development of working processes and activities to increase the efficiency within RegCMC function including continuous improvement initiatives and development of agreed RegCMC strategic frameworks.
  • 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, in a timely manner, to key stakeholders as appropriate.
  • Monitor and influence changes in the global RegCMC environment in alignment with business needs.

 

 

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

  • BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.

Regulatory Skills

  • 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

Leadership/Management Skills

  • Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
  • Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
  • Proven ability to manage projects across global locations/time zones.
  • Proven ability to create strong, productive working relationships in a global setting with many different cultures.
  • Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
  • Competence in people development and management.


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.