Senior Associate Regulatory Affairs – at BioMarin, Apply Now!
BioMarin, a global leader in biotechnology, is hiring a Senior Associate – Regulatory Affairs, Development Programs in London, United Kingdom. Join a passionate team dedicated to advancing human health through cutting-edge genetic research and breakthrough therapies. If you’re driven by innovation and thrive in a collaborative scientific environment, this is your opportunity to make a real difference.
- Job Position: Senior Associate Regulatory Affairs, Development Programs
- Location: London, United Kingdom
BioMarin, a global leader in biotechnology, is hiring a Senior Associate – Regulatory Affairs, Development Programs in London, United Kingdom. Join a passionate team dedicated to advancing human health through cutting-edge genetic research and breakthrough therapies. If you’re driven by innovation and thrive in a collaborative scientific environment, this is your opportunity to make a real difference.
About BioMarin
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.
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.
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.
Education:
- 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.
Equal Opportunity Employer/Veterans/Disabled: An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Keywords: Senior Associate, Regulatory Affairs, Development Programs, BioMarin, London, Genetic Diseases, Drug Development
