Director, Government Programs – Compliance and Infrastructure
Oklo Inc
ERP
Manager, Regulatory CMC
BioMarin Pharmaceutical Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Planning, preparation and submission of global regulatory CMC-related content for Marketing Applications, Post-approval Variations, and periodic reports for North America and international markets
- Ensure submission sections are complete, well-written, and meet relevant requirements
- Collaborate and align with Reg CMC Product Lead regarding change record assessments and regulatory strategy
- Provide strategic regulatory guidance to cross-functional stakeholders for optimal implementation
- Develop and review regulatory documents to ensure completeness and accuracy
- Manage timelines and deliverables to align submissions with program milestones
- Proactively identify issues and escalate to global Reg CMC Product Lead and Portfolio Lead
- Develop relationships with Regulatory Affairs, Technical Development, Sites (internal and external), and Quality to support submission preparation
- Provide regulatory advice to technical subject matter experts based on current Quality (CMC) requirements
- Process documentation requests to support key application activities
- Assist with regulatory authority (FDA, Health Canada) interactions such as pre-Agency meeting requests and briefing packages
- Lead and/or assist in responding to country health authority queries
- Knowledge management of global marketing authorization and post-approval change requirements
- Work in Regulatory and Quality databases via Veeva platform
Requirements
- BA/BS degree in life sciences (chemistry, molecular biology, or similar) desirable
- Advanced degree is a plus
- At least 7 years of experience in Regulatory Affairs CMC or a related discipline in the pharmaceutical or biotechnology industry
- Marketed Products experience required
- Experience in filing post-marketing supplements, INDs, CTAs for pharmaceutical or biologic products in the US and/or Europe
- Thorough understanding of relevant drug development regulations and guidelines
- Thorough understanding of marketing authorization registrations and post-approval change variation guideline
- GMP environment experience (clinical and commercial), with understanding of multi-product facilities
- Outstanding interpersonal and communication (written and verbal) skills
- Proficient with computer and standard software programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory CMCregulatory documentsmarketing applicationspost-approval variationsINDsCTAsdrug development regulationsmarketing authorization registrationsGMPquality requirements
Soft skills
interpersonal skillscommunication skillsstrategic guidancerelationship buildingproblem identificationtimelines managementcollaborationaccuracyproactive escalationcross-functional teamwork
