Sr Manager, Regulatory CMC
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
Regulatory Affairs Sr Manager works with US based project teams and subject matter experts to support the clinical development and life cycle management of biological protein medicinal products in EU and Switzerland. The role involves working closely with in-house CMC teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of the CMC portions of clinical trial applications, post approval applications or other CMC-oriented filings. CMC regulatory expertise with biologics is essential.
For assigned protein medicinal compounds the candidate will be responsible for:
· Providing EU Strategic input on CMC expectations for product development in early and late phase clinical trials
· Providing EU Strategic input on CMC expectations for post approval variations
· Collaboration with internal and external partners to provide high quality submission in line with Company objectives and timelines
· Assessment of manufacturing changes within the Phase 1-3 and post approval environments.
· Planning and execution of submissions and responses to questions
· Interaction and with subject matter experts, as required.
· Management and communication of review outcomes to impacted stakeholders.
· Represent the EU Reg CMC team on process enhancement initiatives
Collaborative, knowledgeable, organized, good and consistent communicator with attention to detail.
Proven time management skills and the ability to prioritize tasks.
Candidate should demonstrate initiative and the ability to work independently. Also must have proven ability to work as part of a cross functional/cultural team.
B.Sc or higher degree in life sciences in biology, chemistry, molecular biology, or similar is reqired Ph.D.is preferred.
Strong knowledge of the manufacturing of biological medicinal products with proven relevant EU CMC Regulatory Affairs experience.
Particular experience required:
· Extensive knowledge and experience of EU CMC Reg Affairs guidelines and regulation relevant to biological medicinal products
· Change control assessment
· IMPD authoring
· Variation/lifecycle submission authoring, reviewing and management
· Interaction with EMA or other Regulatory Authorities.
Travel Requirements: 15%
Interaction with EMA or other Regulatory Authorities.
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.