GRA CMC Manager

We are looking for a

GRA CMC Manager   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:  

• 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.  

• Provide   technical guidance to CMC  Scientists;   may deputize for the CMC Team Lead.  

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.  

• Preparation and review of CMC related information and documentation  required   for tenders, PSURs, DSURs, CCDS/product  information   and promotional materials.  

• Regulatory contribution to annual product quality reviews and risk assessments.  

Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:  

• Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s).  

• May  represent   Global Regulatory Affairs in Project Teams for CMC projects.  

• 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:  

• University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is  advantageous .  

• Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory Affairs.  

• Sound knowledge in natural sciences with a focus on biological medicinal products.  

• Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).  

Competencies  

• Excellent communication, project management, planning, problem  solving   and presentation skills.  

• Strong team   player with a demonstrated ability to develop constructive and effective relationships with peers and management.  

• Strong organizational and follow-up skills, as well as attention to detail.  

• Ability to work with minimal supervision based on sound technical and analytical judgment.  

• Flexibility to work in a global cross-cultural work environment.  

• Microsoft Office skills.  

• Fluent in English and local language.  

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.

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CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .