GRA CMC Scientist — CSL Behring
- Lieu
- Bern
- Contrat
- full-time
- Publié
- Hier
Vue d’ensemble du poste
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:
Responsabilités principales
- Key Responsibilities:
Processus de candidature
- 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
Entreprise et contexte
- 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.
Détails supplémentaires
- 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 et contenu original
- Qualification
- Competencies
Questions sur cette offre
Quel salaire propose CSL Behring pour ce poste ?
CSL Behring indique CHF 77 000 - 116 500 bruts par an pour ce poste à Bern. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose CSL Behring ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec CSL Behring pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Berne ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Berne peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Berne ou avec les RH pendant la candidature.
Comment postuler à ce poste chez CSL Behring ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de CSL Behring sur csl.wd1.myworkdayjobs.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
