Global Regulatory CMC Lead

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• 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

Job Description

The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.

The role holder works closely with Global Manufacturing Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Regulatory Affairs. The Global Regulatory CMC Lead also supports Global Manufacturing and Supply where R&D deliverables are needed for regulatory submissions.

Key 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

Qualifications

Education/Learning Experience/Work Experience

• BSc in Life Science is required. Advanced Degree preferred
• At least 7-10 years of experience are required in CMC Regulatory Affairs. Additional experience in technical development, manufacturing, or analytical is preferred

Skills/Knowledge/Languages

• 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
• Experience with Veeva is preferred

Personal Attributes

• Must demonstrate behaviors in line with Sobi’S core values: Care, Ambition, Urgency, Ownership, and Partnership
• Demonstrate attention to detail and problem-solving abilities
• Exercise good judgement in proactively elevating and communicating actual or potential issues and risks to line management
• Ability to represent Regulatory CMC as a member of project teams and increase the overall knowledge about Regulato