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For Companies At a Glance
- Tasks: Lead submission content planning and manage regulatory operations for innovative biotech projects.
- Company: Join BioMarin, a pioneering biotechnology company transforming genetic discoveries into life-changing medicines.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth in a dynamic environment.
- Other info: Be part of a diverse team dedicated to solving significant health challenges.
- Why this job: Make a real impact in advancing human health through bold science and innovative drug development.
- Qualifications: Experience in regulatory submissions and strong communication skills are essential.
The predicted salary is between 36000 - 60000 £ per year.
Who We Are
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.
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.
Job Summary
The Manager will lead submission content plan creation and management for assigned filings, oversee submission execution activities, and provide regulatory operations expertise to cross-functional program teams.
Key Responsibilities:
- Develop, maintain, and oversee submission content plans across global programs, ensuring alignment with Health Authority requirements and internal standards.
- Collaborate with cross-functional teams to capture deliverables, timelines, and interdependencies in content plans.
- Ensure accuracy, completeness, and compliance of content plans across submission types (IND, CTA, NDA, BLA, MAA, etc.).
- Partner with Regulatory Leads and Publishers to track document readiness and mitigate content risks.
Submission Process Support
- Provide operational guidance on submission standards, templates, and regional requirements.
- Identify and implement process improvements that enhance content planning and submission efficiency.
- Troubleshoot submission-related system or process issues and escalate as appropriate.
Technical and Regulatory Support
- Stay current on regulatory guidance and Health Authority requirements relevant to content planning and eCTD structure.
- Perform impact assessments of new or updated guidance on submission requirements.
- Provide expertise on eCTD specifications and submission lifecycle management.
Required Skills
- Experience in managing regional submission activities for a major filing, (IND, BLA, NDA, sNDA, DMF, Amendments, CTA, ASEAN etc.). including the management of global submission timelines
- Must be highly proficient in MS Office 365(with an emphasis on MS Word)
- Minimum 3-5 years of experience withVeeva Vault RIM
- Expert knowledge of eCTD specifications and requirements
- Must have extensive experience with electronic submissions, specifically eCTD
- Excellent communication skills are required to interact effectively with Regulatory Affairs members and R&D colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues
- Applies good judgment and demonstrates initiative to resolve issues
- Knowledgeable on current regulatory submission standards and industry best practice
- Experience working with electronic document management systems
Education & Experience
- Degree in health or life sciences, including chemistry, molecular biology, or similar. Masters/Bachelors acceptable with relevant experience
- Must have extensive experience with global electronic submissions, specifically eCTD.
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.
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.
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Manager, Regulatory Operations Submissions Management employer: BIOMARIN
Contact Detail:
BIOMARIN Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Regulatory Operations Submissions Management
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at BioMarin. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff. Research BioMarin's recent projects and be ready to discuss how your experience aligns with their mission in regulatory operations.
✨Tip Number 3
Showcase your skills! Bring examples of your past work in managing submissions and compliance to the table. Real-life stories make you memorable.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people at BioMarin.
We think you need these skills to ace Manager, Regulatory Operations Submissions Management
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory operations and submissions management. We want to see how your skills align with the specific requirements mentioned in the job description.
Showcase Your Expertise: Don’t hold back on showcasing your knowledge of eCTD specifications and electronic submissions. We’re looking for someone who knows their stuff, so make it clear how your background fits the bill!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. Use bullet points where possible to make it easy for us to see your key achievements and experiences at a glance.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at BIOMARIN
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and eCTD specifications. Being able to discuss these in detail will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Collaboration Skills
Since the role involves working with cross-functional teams, be ready to share examples of how you've successfully collaborated in the past. Highlight specific projects where your teamwork made a difference in submission outcomes.
✨Be Ready for Technical Questions
Expect questions about your experience with electronic submissions and document management systems. Prepare to discuss your proficiency with MS Office 365 and Veeva Vault RIM, as well as any challenges you've faced and how you overcame them.
✨Demonstrate Problem-Solving Abilities
Think of instances where you identified process improvements or troubleshot issues in submission processes. Sharing these experiences will illustrate your initiative and good judgment, which are key traits for this role.