Sobi - Swedish Orphan Biovitrum AB (publ) · 13 hours ago
Global Regulatory CMC Lead
United States
Full-time
Remote
Senior Level
7+ years expSobi is a specialized biopharmaceutical company dedicated to rare diseases, and they are seeking a Global Regulatory CMC Lead to develop and execute global regulatory CMC strategies for assigned assets. The role involves preparing regulatory submissions and collaborating with cross-functional teams to ensure compliance and successful approvals.
BiotechnologyGeneticsMedicalPharmaceutical
Responsibilities
Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide
Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization, post approval changes and clinical trial applications globally
Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making
Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval
Interact and negotiate with Health Authorities on CMC issues
Develop and maintain project plans and schedules for CMC submissions
Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation
Provide guidance on ICH, FDA, and EU CMC guidelines
Develop and maintain strong relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Sobi’s guidelines
Qualification
Required
BSc in Life Science is required
At least 7-10 years of experience are required in CMC Regulatory Affairs
Demonstrated expertise in global regulatory CMC requirements, including contents of Quality sections
Experience in the new product registrations and CMC lifecycle management
Experience in CMC development during clinical phases is beneficial
Ability to manage interactions with Health Authorities
Strong working knowledge of global regulatory guidelines
Fluency in English
Effective verbal and written communication skills
Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready
Preferred
Advanced Degree preferred
Additional experience in technical development, manufacturing, or analytical is preferred
Experience with Veeva is preferred
Benefits
Competitive compensation for your work
Emphasis on work/life balance
Collaborative and team-oriented environment
Opportunities for professional growth
Diversity and Inclusion
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
We offer a competitive benefits package, to support the health and happiness of our staff.
Company
Sobi - Swedish Orphan Biovitrum AB (publ)
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$825.99M2024-05-08Post Ipo Debt· $274.92M
2023-08-22Post Ipo Equity· $551.07M
2006-09-15IPO
Leadership Team
Guido Oelkers
Chief Executive Officer
Recent News
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2026-01-16
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2026-01-16
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