Regulatory Affairs Manager

Biomarin


Regulatory Affairs Manager


USC or GC preferred


REMOTE

KEY RESPONSIBILITIES:
The RNC Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following:


Development Stage Product
• 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
Commercial Stage Product
• 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, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings.
• Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.
General
• 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


EDUCATION AND EXPERIENCE
• 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