Global GRA/CMC Specialist — Biologics

CSL Plasma Inc.; Bern; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

CSL Behring seeks two GRA CMC Specialists to develop and execute global CMC regulatory strategies for biologic therapies. Based at Bern or other CSL sites, you will coordinate regulatory documentation, assess manufacturing changes, and prepare submissions for marketing and lifecycle variations, working with global teams to ensure compliant, timely responses to health authorities.

You will partner with manufacturing and regulatory colleagues, support inspection readiness, and contribute to

Qualifikationen

• Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field.
• 3 years' experience within the biotechnology, pharmaceutical, or related life sciences industry.
• Experience within Regulatory Affairs, CMC, manufacturing, quality, process development, or a related function.

Aufgaben

• Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes.
• Coordinate the preparation, review, and maintenance of CMC regulatory documentation to support global submissions.
• Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle.
• Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact.
• Prepare and review regulatory content for submissions including marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions.
• Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities.
• Interpret evolving global regulatory requirements and assess their impact on products and development programs.
• Support inspection readiness activities and contribute to continuous improvement of regulatory processes.
• Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance.

Kenntnisse

CMC regulatory strategy

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Project planning

Ausbildung

Degree in Biology/Cood Chemistry/Pharmacy

Jobbeschreibung

CSL Behring seeks two GRA CMC Specialists to develop and execute global CMC regulatory strategies for biologic therapies. Based at Bern or other CSL sites, you will coordinate regulatory documentation, assess manufacturing changes, and prepare submissions for marketing and lifecycle variations, working with global teams to ensure compliant, timely responses to health authorities.

You will partner with manufacturing and regulatory colleagues, support inspection readiness, and contribute to