Manager, Regulatory Information Management & Technology (RIMT)

San Rafael, CA

Employer:

Description

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 3-5 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 and 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.
The salary range for this position is: $115,700 to $155,000.00. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits .

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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