Manager, Regulatory Information Management & Technology (RIMT)

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.

Summary BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.  BioMarin Regulatory Affairs RIMT function has a lead role in overall BioMarin Regulatory Submission system end user technical support.  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  Responsibilities  Veeva RIM System Process and Communication 

• Oversee Regulatory technology and process development activities as needed 

• Manages updates to content plan templates, doc types and other Veeva RIM functional administrative activities  

• Supports system updates to industry regulations that impact regional submission strategies and technologies  

• Collaborate with cross-functional teams to understand submission processes and propose process enhancements with Veeva RIM functionality.  

• Develop and author training materials and lead efforts to implement training to ensure optimal use of processes, and tools related to regulatory submission activities.  

• Create and maintain system documentation, including guidesheets, business process and controlled documents. 

• Identify retraining of individuals, or updates to the training materials as needed.  

• Provide system support for new or updated processes.  

• Support change management and develop communications  

• Participate on Veeva RIM release teams for internal and Veeva system releases 

• Solid understanding of system changes and impacts to the business process 

• Develop communications for information or training purposes  

Technical support 

• Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs 

• Trouble shoot complex system user issues (such as interpreting technical validation errors) 

Additional Responsibilities 

• Stay abreast of new guidance released by health agencies and coach team members on interpretation as needed 

• Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidance 

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-