GRA CMC Specialist — CSL Behring
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
Role overview
Position Purpose
Partnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements.
Supporting digital innovation, enabling capital project initiatives, and managing strategic external partnerships by coordinating and aligning regulatory CMC strategies and activities across the enterprise.
- Position Purpose
- Partnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements.
- and Accountabilities
- Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
- and Experience Requirements Education & Experience
Main responsibilities
- and Accountabilities
- Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
Key requirements
- and Experience Requirements Education & Experience
Application process
- Assess and facilitate the use of digital innovation for Global Regulatory Affairs CMC, including AI/ML applications that manage or support regulatory submission, notification, assessment and intelligence activities.
- Collaborate with Procurement, IT, external vendors, and R&D Global Regulatory Affairs to implement next-generation solutions that enhance the generation of regulatory strategies and execution of regulatory operations.
- Define and monitor KPIs to measure impact of digital initiatives on operational efficiency indicators.
- Manage relationships with outsourcing vendors to support global regulatory CMC activities.
- Serve as contact for external partners, coordinating deliverables, timelines, and compliance across multiple projects and geographies.
- Monitor performance, quality, KPIs, and regulatory readiness of outsourced operations, driving continuous improvement and risk mitigation strategies.
- Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.).
- Ensure timely dissemination of regulatory intelligence to internal stakeholders and integration into strategic planning.
Company and context
- Coordinate key regulatory CMC activities for the Global Regulatory Affairs CMC organization, including change control, due diligence (for potential acquisitions, licensing, and partnerships), template management for quality CTD sections, deviation support, inspection support, and others.
- Support the collaboration with CSL’s Corporate & External Affairs organization to support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies.
- Support the development of strategic and tactical plans for Global Regulatory Affairs CMC, advising senior leadership on regulatory requirements and their implications for project timelines, compliance, and business strategy.
- Contribute to the evaluation of new business opportunities in collaboration with development teams.
- Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements.
- Support the the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network.
- Support the execution of the outsourcing of regulatory activities, including performance monitoring and quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements. Position
Additional details
- This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives. Responsibilities and Accountabilities
- Support the execution of the outsourcing of regulatory activities, including performance monitoring and quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements. Qualifications and Experience Education & Experience
Notes and original content
- This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
- Responsibilities and Accountabilities
- Support the execution of the outsourcing of regulatory activities, including performance monitoring and quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.
- Qualifications and Experience
- Requirements
- Education & Experience
Questions about this listing
What salary does CSL Behring offer for this role?
CSL Behring lists CHF 68'500 - 104'000 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.
