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.
With 6 commercial products, 7 more in the pipeline and over half a billion dollars of revenue, a global footprint in 40 countries, and a personal connection to our patients, BioMarin is the recognized industry leader in rare disease development. Come work in an entrepreneurial environment where you’ll have the resources and infrastructure combined with visibility and opportunity to tangibly impact patent’s lives and the future of our company. This is your chance to be part of something amazing!
If you are an experienced, ambitious Regulatory Affairs professional with track record in department development and streamlining CMC processes along with development and commercial experience with EMA centrally approved drug products we want to talk to you.
- You will be responsible for defining quality and regulatory strategy within the Reg CMC department for commercial and development products
- Manage a team of global Regulatory CMC professionals of 5-10 individuals.
- Help build the capabilities of the Global Reg CMC team
- Explore the use of new regulatory concepts, pathways and new technologies to allow faster access to medicines according to Company objectives
- Proactively strategize Reg CMC aspects for global commercial programs including streamlining preparation and submission of marketing and clinical trial applications.
- Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners
- Represent Regulatory Affairs CMC function on assigned cross-functional project teams to enhance and develop business processes.
- Lead the development of new processes and templates for clinical development and global core dossiers.
- 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 global 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.
- Ability to identify gaps in Reg CMC processes and templates, identify priorities for improvement and drive change.
- 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%.
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.