Global Regulatory CMC Lead

Sobi • Waltham, MA

12d

About The Position

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.

Requirements

• 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
• Demonstrated expertise in global regulatory CMC requirements, including contents of Quality sections
• Experience in the new product registrations and CMC lifecycle management
• 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
• 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 Regulatory CMC role and value
• Ability to assess need, apply experience and develop solutions to complex issues and determine and/or negotiate the most appropriate course of action in a timely manner
• Be independently motivates and detail-oriented

Nice To Haves

• Experience in CMC development during clinical phases is beneficial
• Experience with Veeva is preferred

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees