GRA CMC Specialist

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., · 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.

· 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 Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries., CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

Areas of Expertise

We focus and demonstrate global leadership in three distinct areas-rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.

Rare & Serious Diseases

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Vaccines

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.

Iron Deficiency & Nephrology

With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women’s health, we help patients affected by these conditions to live better, healthier lives.