Regulatory Affairs Manager Jobs

Regulatory Affairs Manager

BioMarin Pharmaceutical

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

51.00 - 75.00 USD / Hour

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Job Description:

The RA Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle. The Manager leads the execution of delegated activities, including preparation for HA interactions and the preparation of regulatory submissions in support of the strategy.

Job Responsibility:

Support the development of the nonclinical / clinical regulatory strategy and plan
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
Collaborate with Reg PM to create and align submission timelines
Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA
Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA
Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s
Oversee the archiving of HA submissions and correspondence
Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications
Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions
Coordinate necessary interactions with INTL in support of INTL MA filings
Attend relevant functional area and project team meetings
Review, understand and stay up to date on regulations, guidelines relevant to responsibilities
Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary
Ensure that the PM timelines and tracker accurately reflect submission plans

Requirements:

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
4+ year experience
Nonclinical / Clinical Regulatory Affairs experience preferred

What we offer:

discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans

Additional Information:

Job Posted:
December 26, 2025

Work Type:

Remote work

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