Regulatory Affairs Senior Manager, Biosimilars
vor 1 Woche
We are seeking a highly experienced Regulatory Affairs Senior Manager to join our Biosimilars Business Unit at Randstad (Schweiz) AG. As a key member of our team, you will be responsible for leading regulatory affairs activities for assigned projects and programs, ensuring compliance with regulatory requirements and supporting commercialization efforts.
Key Responsibilities- Regulatory Leadership: Provide strategic guidance and oversight to regulatory teams, ensuring alignment with business objectives and regulatory requirements.
- Regulatory Vendor Management: Oversee the activities of regulatory vendors, ensuring successful execution of operational activities, tracking, and archiving for assigned products.
- Regulatory Process Development: Lead the development and implementation of regulatory processes, including the establishment and management of KPIs, tracking and monitoring of deviations, and reporting of metrics.
- Regulatory Training and Support: Provide training and support to regulatory colleagues, in-country RA leads, and vendors as applicable, ensuring In-country RA leads training and access is maintained.
- Regulatory Contract Management: Manage and oversee regulatory contracts, SOWs, and PO's, including renewal activities, working closely with procurement, finance, and medical operations.
- Regulatory Quality Management: Manage and support regulatory quality deliverables, including regulatory KPIs, process development, and SOP management, deviation and CAPA management, change controls, inspection support, regulatory intelligence management.
- Regulatory Submission Science and Information Management: Support regulatory submission science and information management with document management, quality control, tracking, and publishing activities.
- Regulatory Policy and Procedure Management: Monitor and assess regulatory policy, guideline, and procedure changes, assessing potential impact, and support the team to keep abreast of current regulatory requirements.
- Regulatory Compliance: Comply with the company's policies and procedures to meet statutory, quality, and business requirements within the overall strategy and objectives of Randstad (Schweiz) AG.
- Education: BS degree in pharmacy, chemistry, biology, pharmacology, or related life sciences subject.
- Experience: 6 to 8+ years pharmaceutical/biotechnology industry with 4 to 6+ years regulatory experience.
- Skills: SME in regulatory processes, good knowledge of applicable regulations, and submission standards/requirements, ability to interpret regulations and guidelines, experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- Personal Qualities: Strong communication and project management abilities in global and virtual teams, strong interpersonal skills, ability to collaborate effectively across project teams, Biogen's innovator business, and with vendors, flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently.
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vor 1 Woche
Baar, Zug, Schweiz Randstad (Schweiz) AG VollzeitAbout the RoleWe are seeking a highly experienced Regulatory Affairs Senior Manager to join our Biosimilars Business Unit at Randstad (Schweiz) AG. As a key member of our team, you will be responsible for leading regulatory affairs activities for assigned projects and programs, ensuring compliance with regulatory requirements and supporting commercialization...
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