Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Senior Manager Biosimilars - Baar, Zug - Randstad (Schweiz) AG
-
Regulatory Affairs Specialist
vor 4 Wochen
Baar, Zug, Schweiz PharmaContext GmbH VollzeitJobbeschreibungWir suchen eine erfahrene Person für die Position des Regulatory Affairs Managers, die sich auf die Arzneimittelzulassung in der Schweiz spezialisiert hat.HauptaufgabenBearbeitung von Neuzulassungsanträgen und Life-cycle Management bestehender ZulassungenKontakt mit dem Schweizerischen Heilmittelinstitut Swissmedic und mit Auftraggebern im...
-
Senior Manager, Regulatory CMC Lead
vor 4 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleWe are seeking a highly skilled Senior Manager, Regulatory CMC Lead to join our team at Biogen. In this role, you will be responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products.Key...
-
Quality Assurance Manager
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout the Role:Job Description:Biogen is seeking a highly skilled and experienced Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.Key Responsibilities:Develop and implement quality management systems to ensure...
-
Senior Manager, Regulatory CMC Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleIn this pivotal position, you will provide expert Regulatory CMC guidance to shape the global regulatory strategy, operations, and planning for assigned projects/products. Your responsibilities will include preparing and compiling submission/documentation for small molecule projects, collaborating with the Regulatory CMC Lead and key...
-
Regulatory Compliance Specialist
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout the RoleJob SummaryWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our medicinal products, as well as ensuring compliance with regulatory requirements.Key ResponsibilitiesQuality...
-
Senior Manager, Regulatory CMC Small Molecule Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout the RoleIn this position, you will provide Regulatory CMC expertise to support the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products. Your responsibilities will include preparation and compilation of submission/documentation for specific small molecule projects,...
-
Quality Assurance Manager
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout the RoleJob SummaryWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesQuality Assurance and ComplianceDevelop and implement quality...
-
Senior Quality Release Manager
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitJob SummaryBiogen Idec is seeking a highly skilled and experienced Senior Quality Release Manager to lead the commercial release team and ensure the continuous supply of compliant medicinal products to approved markets. The successful candidate will be responsible for managing the release process, ensuring compliance with regulatory requirements, and...
-
Regulatory CMC Small Molecules Team Lead
vor 3 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout this roleThe Regulatory CMC Small Molecules Team Lead will be responsible for leading a team of regulatory professionals in the development and implementation of global CMC regulatory strategies for small molecule products. This role will require strong leadership and communication skills, as well as the ability to work effectively in a matrixed...
-
Senior Director of Cyber Security
vor 4 Wochen
Baar, Zug, Schweiz Aman VollzeitJob Title: Senior Director of Cyber SecurityAman is seeking a highly experienced and skilled Senior Director of Cyber Security to lead its global cybersecurity strategy and operations. The successful candidate will play a critical role in protecting the organization's digital infrastructure, safeguarding guest and corporate data, and ensuring the resilience...
-
Pharmaceutical Quality Control Lead
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout the RoleJob SummaryWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesQuality Assurance and ComplianceDevelop and implement quality...
-
Cyber Security Director
vor 2 Wochen
Baar, Zug, Schweiz Aman VollzeitJob Title: Senior Director of Cyber SecurityAt Aman, we are seeking a highly experienced and skilled Senior Director of Cyber Security to lead our global cybersecurity strategy and operations. This is a critical role that requires a deep understanding of cybersecurity frameworks, regulatory requirements, and cutting-edge security...
-
Senior Release Manager
vor 2 Wochen
Baar, Zug, Schweiz Biogen Idec VollzeitAbout This RoleAs a Senior Release Manager at Biogen, you will be responsible for leading the commercial release team to ensure continuous supply of compliant Medicinal Products to approved markets. You will also act as a Responsible Person (RP) delegate for Active Pharmaceutical Ingredients (API), Drug Substances (DS), and Drug Products (DP) technical...
-
Senior Investment Manager
vor 4 Wochen
Baar, Zug, Schweiz Lucas Partners VollzeitJob DescriptionLucas Partners is seeking a highly skilled and experienced Senior Investment Manager to join our team. As a key member of our investment team, you will be responsible for identifying and evaluating investment opportunities, conducting due diligence, and making investment recommendations to our clients.Key Responsibilities:Conduct thorough...
-
Senior Manager, Technology Transfer
Vor 7 Tagen
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleThe Sr. Engineer III will be responsible for leading technology transfer activities within the Switzerland internal drug substance manufacturing site. This includes providing strategic leadership and direction for the technology transfer matrix, ensuring adherence to the technology transfer business process, and coordinating reports/data to...
-
Cyber Security Director
vor 4 Wochen
Baar, Zug, Schweiz Aman VollzeitSenior Director of Cyber SecurityAman is seeking a highly experienced and visionary Senior Director of Cyber Security to lead its global cybersecurity strategy and operations. Reporting directly to the Chief Information and Technology Officer (CITO), this senior leader will play a critical role in protecting the organization's digital infrastructure,...
-
Senior Manager, Supply Chain Optimization
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleAs the Senior Manager, Supply Chain Optimization, you will be responsible for building and maintaining positive relationships with vendors, suppliers, and strategic partners to ensure performance is aligned with company needs. You will play a key role in optimizing expenses and streamlining supply chain costs, while strengthening our core...
-
Quality Assurance Manager
vor 3 Wochen
Baar, Zug, Schweiz Biogen VollzeitJob DescriptionAbout the Role:Location: Baar, SwitzerlandIn this role, you will act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR 812.212.1, Arts., 12, 13, 17, 18 and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen...
-
Senior Manager, Supply Chain Optimization
vor 3 Wochen
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleAs the Senior Manager, Supply Chain Optimization, you will be responsible for building and maintaining positive relationships with vendors, suppliers, and strategic partners to ensure performance is aligned with company needs. You will play a key role in optimizing expenses and streamlining supply chain costs, while strengthening our core...
-
Quality Assurance Manager
vor 1 Monat
Baar, Zug, Schweiz Biogen VollzeitJob Description Overview of the Position: Location: Baar, Switzerland In this capacity, you will serve as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), in accordance with the Swiss Medicinal Products Licensing Ordinance (MPLO) and related regulations, representing Biogen Switzerland AG. The RP/FvP acts as...
Regulatory Affairs Senior Manager Biosimilars
vor 2 Monaten
We are seeking a highly skilled Regulatory Affairs Senior Manager to join our Biosimilars Business Unit. 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:- Lead regulatory affairs activities for assigned projects and programs, including securing stakeholder alignment and providing oversight and reporting on project progress.
- Responsible for oversight of regulatory vendors, including day-to-day oversight, tracking, and archiving for assigned products, as well as implementation of vendor oversight plans and management of KPIs.
- 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.
- Manage and oversee regulatory contracts, SOWs, and PO's, including renewal activities, working closely with procurement, finance, and medical operations.
- Lead assigned process development or improvement activities, including planning, authoring, regulatory and cross-functional alignment, documentation, implementation, and training as needed.
- Manage and support regulatory quality deliverables, including regulatory KPIs, process development, and SOP management, deviation and CAPA management, change controls, inspection support, and regulatory intelligence management.
- Support regulatory submission science and information management with document management, quality control, tracking, and publishing activities.
- Monitor and assess regulatory policy, guideline, and procedure changes, assessing potential impact, and support the team to keep abreast of current regulatory requirements.
- Comply with the company's policies and procedures to meet statutory, quality, and business requirements within the overall strategy and objectives of Biogen and to ensure regulatory compliance.
- Responsible for planning and implementing defined regulatory strategies, and coordination and filing of all appropriate regulatory submissions for assigned projects and programs.
- Oversight and management of regulatory in-country A&Ds, workload assignments & deliverables, prioritization, and troubleshooting, working closely with affiliate and distributor teams to ensure successful execution of biosimilar regulatory responsibilities.
- Responsible for the development of core aRMMs and for leading their customization, submission, approval, and dissemination across markets, as well as implementation of updates to approved aRMMs.
- Responsible for the implementation of Biogen's Biosimilar labeling strategy, liaising with cross-functional and local regulatory teams, and ensuring strategic partner alignment for successful execution.
- Oversee regulatory review of promotional materials, sales training materials, and other external communications, negotiating regulatory compliance within established risk parameters.
- Provide regulatory support and guidance to brand teams, supply & planning, quality, manufacturing, logistics functions on regulatory activities and issues as needed.
- BS degree in pharmacy, chemistry, biology, pharmacology, or related life sciences subject.
- 6 to 8+ years pharmaceutical/biotechnology industry experience with 4 to 6+ years regulatory experience.
- SME in regulatory processes.
- Good knowledge of applicable regulations, and submission standards/requirements, with the ability to interpret regulations and guidelines.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
- Strong communication and project management abilities in global and virtual teams.
- Strong interpersonal skills and the ability to collaborate effectively across project teams, Biogen's innovator business, and with vendors.
- Ability to work independently with minimal supervision.
- Competent in the use of electronic document management tools.
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks.
