GRA CMC Scientist — CSL Behring
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
Role overview
We are looking for a GRA CMC Scientist to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management.
In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams worldwide.
- We are looking for a GRA CMC Scientist to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management.
- In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams worldwide.
- Key Responsibilities:
Main responsibilities
- Key Responsibilities:
Application process
- Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
- Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.
- Serve as primary regulatory liaison with technical experts; support GMP inspections and inspection readiness.
- Interpret regulatory guidelines and requirements; prepare impact assessments and contribute to process improvements.
- Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.
- Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions.
- Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.
- Supports scheduling and prioritization of CMC related submissions. Qualification
Company and context
- Provide technical guidance to Provide technical guidance to the organization
- Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
- Maintenance of the content of relevant parts of the regulatory dossiers.
- Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g.
- MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account.
- This may include technical authoring of dossier narratives and other regulatory CMC documentation.
- Timely provision of high-quality responses to CMC related Health Authority questions.
- Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g.
- CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
- Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.
Additional details
- Supports scheduling and prioritization of CMC related submissions.
- Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
Notes and original content
- Qualification
- Competencies
Questions about this listing
What salary does CSL Behring offer for this role?
CSL Behring lists CHF 77'000 - 116'500 gross per year for this position in Bern. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does CSL Behring offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with CSL Behring during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Bern?
EU/EFTA residents living in the border zone of the country adjoining Canton Bern can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Bern's cantonal migration office or with HR during the application.
How do I apply for this position at CSL Behring?
Use the "Apply now" button on this page — it links directly to CSL Behring's original listing at csl.wd1.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
