Global Regulatory CMC Strategist

Biopharma Careers; Bern; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Zusammenfassung

CSL Behring in Bern, Switzerland seeks a regulatory affairs professional specializing in CMC to partner with Global Regulatory Affairs, Global Operations, and R&D to shape regulatory strategy and ensure timely submissions for plasma-derived therapies.

The role emphasizes digital innovation, collaboration with external partners, and effective communication to align regulatory activities with enterprise objectives.

Qualifikationen

• Degree in biological or chemical sciences required; advanced degree preferred.
• 5+ years in regulatory roles within biologics or plasma industries.
• Strong knowledge of global regulations and standards for drug product development and lifecycle.
• Experience authoring and managing regulatory submissions at federal/state levels.
• Ability to lead cross-functional teams and influence stakeholders.

Aufgaben

• Develop global regulatory CMC strategies for enterprise projects.
• Facilitate digital innovation and AI/ML in regulatory operations.
• Manage outsourcing vendors and external partnerships for CMC activities.
• Monitor and interpret evolving global CMC regulations (FDA, EMA, PMDA, NMPA).
• Coordinate CMC activities: change control, due diligence, templates, deviations, inspections.
• Support legislative and regulatory policy initiatives with Corporate & External Affairs.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Global regulatory knowledge

Communication

Ausbildung

Bachelor's degree in biological or chemical sciences

Advanced degree preferred (MS/PhD)

Jobbeschreibung

CSL Behring in Bern, Switzerland seeks a regulatory affairs professional specializing in CMC to partner with Global Regulatory Affairs, Global Operations, and R&D to shape regulatory strategy and ensure timely submissions for plasma-derived therapies.

The role emphasizes digital innovation, collaboration with external partners, and effective communication to align regulatory activities with enterprise objectives.