This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, CMC Regulatory Affairs in Switzerland.
As Director of CMC Regulatory Affairs, you will lead global regulatory strategy for complex biological products, ensuring compliance and enabling timely development, approval, and uninterrupted supply. You will collaborate across R&D, supply, quality, and commercial teams to provide regulatory guidance, mitigate risks, and streamline submission processes. This role offers high visibility and impact, balancing strategic oversight with practical problem-solving, mentoring team members, and shaping regulatory approaches for innovative biologics. You will also influence cross-functional decisions, support major inspections, and ensure regulatory excellence throughout the product lifecycle. The position provides an opportunity to contribute to global projects while developing professional growth and leadership skills.
Accountabilities
Lead CMC regulatory strategy for investigational and early commercial biological products across global teams
Advise cross-functional stakeholders on regulatory requirements, guidelines, policies, and strategies to expedite submissions and approvals
Own submission content, ensuring regulatory compliance for clinical trials, product release, and stability
Identify regulatory risks and propose mitigation plans to senior leadership
Support inspections and manage regulatory interactions, providing guidance for complex regulatory scenarios
Mentor and develop regulatory colleagues, potentially managing direct reports
Ensure regulatory compliance for change control requests, including supply transfers and lifecycle management activities
Collaborate with internal and external networks to maintain regulatory alignment and maximize manufacturing flexibility
Requirements
Degree in biological sciences, chemistry, pharmacy, engineering, or a related scientific discipline
Extensive CMC regulatory experience in biopharmaceuticals, including development and manufacturing requirements
Strong understanding of global regulatory frameworks and agency engagement
Experience leading regulatory teams or managing direct reports is preferred
Knowledge of lifecycle management, post-approval regulatory activities, and complex biologics (e.g., cell & gene therapy, therapeutic proteins)
Proven track record preparing or contributing to global CMC submissions
Excellent communication, collaboration, and problem-solving skills with ability to manage multiple projects and priorities
Ability to mentor junior colleagues and influence cross-functional teams effectively
Advanced degree (MSc or PhD) is an advantage
Benefits
Competitive compensation and performance-based incentives
Comprehensive health, dental, and vision coverage
Retirement/pension contributions according to local norms
Hybrid work model balancing remote and on-site collaboration
Paid vacation, public holidays, and leave benefits
Professional development opportunities and support for career growth
Exposure to high-impact, innovative biologics programs on a global scale
Why Apply Through Jobgether? We use an
AI-powered matching process
to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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As Director of CMC Regulatory Affairs, you will lead global regulatory strategy for complex biological products, ensuring compliance and enabling timely development, approval, and uninterrupted supply. You will collaborate across R&D, supply, quality, and commercial teams to provide regulatory guidance, mitigate risks, and streamline submission processes. This role offers high visibility and impact, balancing strategic oversight with practical problem-solving, mentoring team members, and shaping regulatory approaches for innovative biologics. You will also influence cross-functional decisions, support major inspections, and ensure regulatory excellence throughout the product lifecycle. The position provides an opportunity to contribute to global projects while developing professional growth and leadership skills.
Accountabilities
Lead CMC regulatory strategy for investigational and early commercial biological products across global teams
Advise cross-functional stakeholders on regulatory requirements, guidelines, policies, and strategies to expedite submissions and approvals
Own submission content, ensuring regulatory compliance for clinical trials, product release, and stability
Identify regulatory risks and propose mitigation plans to senior leadership
Support inspections and manage regulatory interactions, providing guidance for complex regulatory scenarios
Mentor and develop regulatory colleagues, potentially managing direct reports
Ensure regulatory compliance for change control requests, including supply transfers and lifecycle management activities
Collaborate with internal and external networks to maintain regulatory alignment and maximize manufacturing flexibility
Requirements
Degree in biological sciences, chemistry, pharmacy, engineering, or a related scientific discipline
Extensive CMC regulatory experience in biopharmaceuticals, including development and manufacturing requirements
Strong understanding of global regulatory frameworks and agency engagement
Experience leading regulatory teams or managing direct reports is preferred
Knowledge of lifecycle management, post-approval regulatory activities, and complex biologics (e.g., cell & gene therapy, therapeutic proteins)
Proven track record preparing or contributing to global CMC submissions
Excellent communication, collaboration, and problem-solving skills with ability to manage multiple projects and priorities
Ability to mentor junior colleagues and influence cross-functional teams effectively
Advanced degree (MSc or PhD) is an advantage
Benefits
Competitive compensation and performance-based incentives
Comprehensive health, dental, and vision coverage
Retirement/pension contributions according to local norms
Hybrid work model balancing remote and on-site collaboration
Paid vacation, public holidays, and leave benefits
Professional development opportunities and support for career growth
Exposure to high-impact, innovative biologics programs on a global scale
Why Apply Through Jobgether? We use an
AI-powered matching process
to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#J-18808-Ljbffr