216 Permanent, Scientific jobs in Kingston Upon Thames

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases. This position focuses on providing regulatory affairs support to both ongoing development programs as well as approved product lifecycle activities. This individual will help provide operational support to implement the strategy for both the development programs and marketed products in Europe. Responsibilities Development Stage Product

• Support the EU Lead with regards planning, preparation, and submission of clinical trials as well as other Health Authority Interactions in Europe and Globally.
• Assist with selected planning, document development and meeting execution activities in preparation for EMA meetings / interactions.
• With oversight by EU lead, develop and coordinate content for EU regulatory submissions, for example Orphan Drug designation, Module 1 of EU MAA
• Assist with development of the EU submissions for eg PRIME and Orphan Drug Designation, ATMP classification,
• Ensure high quality content that adheres to regulations and guidance.
• Support the maintenance of EU CTAs throughout the life of the studies, may participate in e.g. Study Execution Teams for assigned products for EU specific discussions and considerations
• Collaborate with Regulatory Project Management to create and align submission timelines,
• Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to EMA
• Oversee the archiving of EMA submissions and correspondence
Commercial Stage Products: in addition to many of the responsibilities outlined above on occasion you may be also asked to support EU lead on commercial stage assets.
• assist with development of post-approval submissions including variations, MA renewals, annual reports for CMA's/EC MA's, PIP modifications, and required submissions such as PBRERS
• Assist with activities related to regulatory compliance and transparency, eg EMA Policy 0070, EudraCT postings, sunset clause etc, 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.
  
  BS degree (advanced degree desirable) in life sciences or experience in drug development that allows for sufficient knowledge in this area.
• Previous experience being involved with planning and executing Health Authority Submissions.
Experience
• Proven ability to manage projects as a part of an interdisciplinary team with experience in managing clinical trial submissions
• Ideally someone with Clinical Trial Experience under the Clinical Trial Regulations
• Preferable to have experience regarding the preparation for key regulatory meetings.
• Prior experience managing regulatory submissions to ensure successful in time submissions to support the strategic and operational objectives.
• Prior experience supporting development of complex briefing documents
• Good understanding of relevant drug development regulations and guidelines
• Proficient with computer and standard software programs, ideally experience with SAVVi
Effective task planning and coordination abilities with managing working with colleagues in different time zones.

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.