Sr Director, Regulatory CMCLocation London, United Kingdom Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
If you’re an experienced, ambitious Regulatory Affairs professional with deep knowledge in CMC along with development and commercial experience with EMA centrally approved drug products we want to talk to you.
- You will be responsible for defining EU CMC Regulatory strategy for commercial and development programs and ensuring that work is carried out to Company priorities and timelines.
- Proactively manage EU CMC aspects for global commercial programs including overseeing preparation and submission of marketing and clinical trial applications.
- You will represent BioMarin EU Reg CMC Department at Regulatory authority meetings.
- Manage and develop direct reports in the EU Reg CMC team
- Research and interpret EU and Swiss CMC regulations to provide regulatory guidance to Quality, Manufacturing, Process Development and other functional groups.
- Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
- Represent the EU Regulatory Affairs CMC function on assigned cross-functional project teams to enhance and develop business processes.
- Managing interactions with EMA and SwissMedic for assigned project to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
- B.Sc or higher degree in life sciences in biology, chemistry, molecular biology, or similar is desirable.
- 10+ years in Regulatory Affairs in a global pharmaceutical and/or Biotechnology Company with expertise in commercial biologics/large molecules and deep understanding of lifecycle as well as Phase 1-3.
- Thorough understanding of relevant drug development regulations and guidelines is essential.
- Prior success with communication and influencing global teams on matters of EU Reg CMC strategy for commercial and development programs.
- Prior success filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experience desired.
- Understanding of complex biological manufacturing processes and experience in assessing post-approval changes is required.
- Experience with small molecules would be beneficial.
- At least 4 years of previous supervisory experience managing and developing a team is required.
- Demonstrated ability to coach, train and mentor teams.
- Outstanding interpersonal and communication (written and verbal) skills is required
- Strong writing and editing skills for technical documentation.
- Proficient with computer and standard software programs.
- Able to travel 30%.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.