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- Tasks: Support regulatory affairs for clinical trials and product lifecycle activities in Europe.
- Company: BioMarin is a pioneering biotech firm focused on transforming genetic discoveries into life-changing medicines.
- Benefits: Enjoy a collaborative environment, opportunities for growth, and the chance to make a real impact.
- Why this job: Join a team dedicated to innovative science and improving lives through groundbreaking therapies.
- Qualifications: BS in life sciences or relevant experience; project management and regulatory submission skills preferred.
- Other info: This role offers a unique opportunity to work on first-in-class therapeutics in a dynamic setting.
The predicted salary is between 36000 - 60000 £ per year.
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.
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- 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.
- BS degree (advanced degree desirable) in life sciences or experience in drug development that allows for sufficient knowledge in this area.
- 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.
Senior Associate Regulatory Affairs, Development Programs employer: BIOMARIN
Contact Detail:
BIOMARIN Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Associate Regulatory Affairs, Development Programs
✨Tip Number 1
Familiarise yourself with the latest EU regulations and guidelines related to regulatory affairs. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with EMA submissions. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios faced in regulatory affairs, particularly those related to clinical trial submissions and post-approval processes. Being able to discuss these topics confidently will set you apart.
✨Tip Number 4
Showcase your project management skills during discussions. Highlight any experience you have in coordinating interdisciplinary teams or managing timelines, as this is crucial for the Senior Associate role at BioMarin.
We think you need these skills to ace Senior Associate Regulatory Affairs, Development Programs
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Senior Associate Regulatory Affairs position. Tailor your application to highlight relevant experiences that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your previous experience in regulatory affairs, particularly in managing clinical trial submissions and interactions with health authorities. Use specific examples to demonstrate your expertise.
Showcase Your Skills: Make sure to showcase your project management skills and your ability to work within interdisciplinary teams. Mention any experience you have with regulatory compliance and drug development regulations, as these are crucial for the role.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also conveys your passion for biotechnology and your commitment to advancing human health. Personalise it to reflect your understanding of BioMarin's mission and values.
How to prepare for a job interview at BIOMARIN
✨Know Your Regulatory Affairs
Make sure you have a solid understanding of regulatory affairs, especially in the context of clinical trials and submissions. Brush up on EU regulations and guidelines, as well as any recent changes that may affect the role.
✨Showcase Your Project Management Skills
Be prepared to discuss your experience managing projects within interdisciplinary teams. Highlight specific examples where you successfully coordinated submissions or navigated complex regulatory processes.
✨Prepare for Key Regulatory Meetings
Since this role involves preparing for EMA meetings, think about your past experiences with such interactions. Be ready to explain how you contributed to successful outcomes in previous roles.
✨Demonstrate Your Collaborative Spirit
This position requires collaboration across various teams and time zones. Share examples of how you've effectively worked with diverse groups to achieve common goals, showcasing your communication and coordination skills.
