GRA CMC Scientist

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

At CSL, our work is driven by a simple purpose: to save lives and protect the health of people around the world. We are seeking two GRA CMC Scientists to be based at either of the following sites: Bern (Switzerland), Waltham (US) or Melbourne (Australia).

You will play a critical role in developing and executing global Chemistry, Manufacturing and Controls (CMC) regulatory strategies that support the development, registration, and lifecycle management of innovative biologic therapies.

Working within a highly collaborative global environment, you will partner with technical experts, manufacturing teams, and regulatory colleagues to ensure high-quality, compliant regulatory submissions that enable patients to access life-changing therapies.

Your Responsibilities

• 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.

Your Qualifications, Skills and Experience

To be successful in this role you will bring:

• 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.
• Understanding of regulatory requirements associated with biological medicinal products.
• Knowledge of regulatory frameworks within Australia and experience preparing or contributing to regulatory submissions.
• Strong communication and stakeholder management skills.
• Excellent planning, project management, and organisational abilities to manage competing priorities
• Analytical thinker with strong problem-solving capability.
• Ability to influence and collaborate across diverse, global teams.