Global CMC Regulatory Scientist for Biologics

CSL Vifor; Bern; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Zusammenfassung

CSL Vifor in Bern seeks two GRA CMC Scientists to be based in Bern, Switzerland, or at sites in the US or Australia. You will develop global CMC regulatory strategies for biologics, coordinate regulatory documentation, and support submissions and inspections.

Ideal candidates have 3+ years in biotech/pharma, with experience in regulatory affairs, CMC, and regulatory submissions, and strong communication and project management skills for global teams.

Qualifikationen

• 3 years' experience in biotech/pharma industry.
• Experience in regulatory affairs, CMC, or related function.
• Knowledge of regulatory frameworks for biological products.

Aufgaben

• Develop and implement global CMC regulatory strategies.
• Coordinate preparation and maintenance of CMC documentation.
• Ensure regulatory dossiers remain accurate, current, and compliant.
• Partner with cross-functional teams to assess changes and regulatory impact.
• Prepare and review regulatory content for submissions and responses.
• Provide regulatory input into development projects and risk assessments.
• Interpret evolving regulatory requirements and assess impact on products.

Kenntnisse

Regulatory affairs

CMC

Biotechnology

Project management

Stakeholder management

Regulatory submissions

Communication skills

Analytical thinking

Cross-functional collaboration

Ausbildung

Bachelor's degree in science

Jobbeschreibung

CSL Vifor in Bern seeks two GRA CMC Scientists to be based in Bern, Switzerland, or at sites in the US or Australia. You will develop global CMC regulatory strategies for biologics, coordinate regulatory documentation, and support submissions and inspections.

Ideal candidates have 3+ years in biotech/pharma, with experience in regulatory affairs, CMC, and regulatory submissions, and strong communication and project management skills for global teams.