Global Regulatory CMC Lead

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 Sobis 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 SobiS 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

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to

Remote Work :

Yes

Employment Type :

Full-time