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.
BioMarin Regulatory Operations (RegOps) function has a lead role in overall BioMarin Regulatory Submission activities. Specifically, this team develops and maintains submission processes, system templates, standards, guide sheets and training for all Regulatory submission types. This group also provides cross-department training to system user issues involved in the preparation of materials for submission.
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:
Submission Content Plan Oversight and Management
* 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 with Veeva 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.