Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Global Regulatory CMC Group Lead

Role & FunctionThe Global Regulatory CMC Group Lead will manage a small team of Regulatory CMC Leads and oversee the global regulatory CMC strategy for assigned Sobi assets in development, lead the preparation of the CMC sections of IND/CTA, MAA/NDA, BLA as well as assess the filing strategy globally of post-approval changes. The role holder will work closely with Global Manufacturing Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Regulatory. The Regulatory CMC Lead will also support 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
• Lead and mentor a team of Regulatory CMC Leads
• Compile or assist in writing CMC sections of regulatory submissions including clinical trial and variations/supplements as well as registration submissions worldwide
• Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them
• Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval
• Interact with Regulatory Authorities on CMC issues
• Develop and maintain project plans and schedules for CMC submissions
• Evaluate proposed manufacturing changes for global impact 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 the appropriate database according to Sobi’s guidelines
• Manage team’s budget and prepare succession and employee backup plans

Qualifications

• BSc in Life Science. Advanced Degree preferred
• At least 12 years of experience are required in CMC Regulatory Affairs
• Demonstrated expertise in global CMC regulatory
• Experience managing teams and plan budgets
• Experience in the new product registrations
• Ability to manage interactions with Health Authorities
• Strong working knowledge of global regulatory guidelines
• Experience with Veeva is beneficial
• Experience with biologics is beneficial

Personal attributes• Ability to successfully manage employees and resolve potential conflicts • Demonstrate attention to detail and problem-solving abilities. • Exercise good judgement in elevating and communicating actual or potential issues to line management. • Excellent written and oral communication skills are required • Ability to represent CMC Regulatory Submissions as a member of project teams • 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 • Fluency in English • 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. Salary Range: 170k-230k In addition, you must demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.

LocationThe position will be based in United States.

Reporting toHead of Regulatory CMC, Medical Devices and Combination Products

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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