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Gehaltsübersicht für Regulatory Affairs Manager in Schweiz

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Gehaltsübersicht für Regulatory Affairs Manager in Schweiz

102 630 ₣ Durchschnittliches Monatsgehalt

Durchschnittliches Gehaltsniveau in den letzten 12 Monaten: "Regulatory Affairs Manager in Schweiz"

Währung: CHF USD Jahr: 2021 2020 2019
Das Balkendiagramm zeigt die Änderung des Gehaltsniveaus in der Regulatory Affairs Manager Branche in Schweiz

Verteilung des Stellenangebots "Regulatory Affairs Manager" in Schweiz

Währung: CHF
Wie die Grafik zeigt, in Schweiz gilt Graubünden als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Kanton Zug. Den dritten Platz nimmt Basel-Stadt ein.

Ranking der Kantone in Schweiz gemäß dem Gehaltsniveau für den Beruf "Regulatory Affairs Manager"

Währung: CHF
Wie die Grafik zeigt, in Schweiz gilt Graubünden als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Kanton Zug. Den dritten Platz nimmt Basel-Stadt ein.

Ranking der ähnlichen Stellenangebote gemäß dem Gehaltsniveau in Schweiz

Währung: CHF
Unter den ähnlichen Berufen in Schweiz gilt Global als der bestbezahlte Beruf. Laut unserer Webseite beträgt das Durchschnittseinkommen 123889 CHF. An zweiter Stelle folgt Fonds mit dem Gehalt von 120000 CHF und den dritten Platz nimmt Responsable De Produits mit dem Gehalt von 110000 CHF ein.

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Regulatory Affairs Manager
Coopers Group AG, Zug
Tasks & Responsibilities:         Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:Provides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific education;Provides qualification and classification of the development object and related submission strategy;Interfaces with the correspondent RA-FL for submission strategies, planning and support;Escalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.Administration of Product declarations, Certificates and other, similar documents         Global Regulatory Affairs Manager - interaction with other regulatory functions:Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.Inform Global Regulatory Affairs Business areas about changesInform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management          Global Regulatory Affairs Manager - interaction with functions other than regulatory functions:Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.Provide support for specific topic/questions           Global Regulatory Affairs Manager-General Task:Define and provide Training on Regulatory submission topicsMonitor regulatory requirements, including communication and distribution in a level appropriate mannerImplementation of divisional and local-strategies Requirements:Minimum 3/4 years in hands-on global regulatory affairs Experience in global regulatory affairs working on development projects in medical devices (MD or IVD) Experience in industry Experience with software (working with instruments) Master degree (microbiology or chemistry) or an engineering degree RWD knowledge / understandingExcellent communications and negotiations skills
Regulatory Affairs Manager
Coopers Group AG, Zug
 1)           Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:Provides regulatory support to the R&D Project teams with the applicable Design Control processesProvides team members ad hoc specific education;Provides qualification and classification of the development object and related submission strategy;Interfaces with the correspondent RA-FL for submission strategies, planning and support;Escalates project related regulatory issues;Review of labellingAssemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.Administration of Product declarations, Certificates and other, similar documents 2)           Global Regulatory Affairs Manager - interaction with other regulatory functions:Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.Inform Global Regulatory Affairs Business areas about changesInform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management 3)           Global Regulatory Affairs Manager - interaction with functions other than regulatory functions:Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products.Provide support for specific topic/questions 4)           Global Regulatory Affairs Manager-General TaskDefine and provide Training on Regulatory submission topicsMonitor regulatory requirements, including communication and distribution in a level appropriate mannerImplementation of divisional and local-strategies Must haves:Minimum 3/4 years in hands-on global regulatory affairs Experience in global regulatory affairs working on development projects in medical devices (MD or IVD) Experience in industry Experience with software (working with instruments) Master degree (microbiology or chemistry) / engineering or programming degree RWD knowledge / understandingExcellent communications and negotiations skills Nice to haves:Fluency in Spanish
Regulatory Affairs Manager APAC - Geneva
OM PHARMA, Geneve, Switzerland
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases. It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams. The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances. For more information, please visit: ompharma.com. Regulatory Affairs Manager APAC - Geneva We are looking for a Regulatory Affairs Manager APAC for our biotech production site in Geneva. Reporting to the RA Regional Head/International, you are responsible for assigned regulatory projects related to the APAC region. Your main responsibilities are as follows: Create regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc. Ensure successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the APAC region, especially China Act as a point of contact for all regulatory affairs matters concerning the APAC region Plan all regulatory activities with the assigned partner companies and ensure timely execution Communicate with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels Improve business performance by shortening time to market and speed of product change implementation Work with the legal department on the regulatory review of existing and establishment of new license agreements Ensure the accuracy and completeness of assigned database entries according to internal guidelines To carry out this mission, we are looking for a person with the following profile: Degree in the fields of Life Sciences (Master, Pharmacist or PhD) At least 5 years of experience in Regulatory Affairs related to APAC countries / China Ability to analyze the regulatory requirements (particularly APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies Fluent (written and spoken) in English and ideally Chinese (would be strongly valued), French is a plus You describe yourself as an analytical and result-oriented person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. You also demonstrate strong leadership, entrepreneurship and negotiation skills, and you like to interact with various stakeholders. Are you interested in this opportunity? Apply now and join OM Pharma!
Regulatory Affairs Manager
Wyss Center for Bio and Neuroengineering, Genf
Printed copies are uncontrolled unless signed by the appropriate authorities - Check you are using the latest version - Page 1 of 2 Job Description Title: Regulatory Affairs Manager Position: Permanent (100%) Posted: 29th September 2021 Travel time: Up to 10 % in EU and internationally (mostly United States) Location: Wyss Center for Bio and Neuroengineering, Campus Biotech, Geneva Switzerland About the Wyss Center for Bio and Neuroengineering, Geneva, Switzerland The Wyss Center is an independent, non-profit research and development organization that advances our understanding of the brain to realize therapies and improve lives. The Wyss Center staff, together with the Center’s academic, clinical and industrial collaborators, pursue innovations and new approaches in neurobiology, neuroimaging and neurotechnology. The Wyss Center advances reveal unique insights into the mechanisms underlying the dynamics of the brain and the treatment of disease to accelerate the development of devices and therapies for unmet medical needs. The Center was established by a generous donation from the Swiss entrepreneur and philanthropist Hansjörg Wyss in 2014. Additional resources from funding agencies and other sources help the Wyss Center accelerate its mission. About the Position The Regulatory Affairs Manager will work both independently and collaboratively at the Wyss Center to support the clinical and regulatory affairs activities in neurotechnology, neuroimaging and neurobiology projects that are designed to collect real-time neural signals, to transmit multichannel recordings and to provide closed loop control signals for a range of applications. The ideal candidate will contribute to the regulatory activities of the Wyss Center and will author the technical documentation for submission to regulatory bodies for clinical studies and/or CE marking, as part of the Wyss Center’s mission to develop and translate innovative medical devices and therapies to the market. He/she will report directly to the Center’s Chief Operating Officer. Key responsibilities In his/her position, the Regulatory Affairs Manager will have a broad set of responsibilities which includes: • Support the translation of products under development to human clinical trials by reviewing and compiling the technical documentation necessary for regulatory submissions in Switzerland, Europe, and United States. • Define the regulatory strategy for Wyss Center’s projects and drive the interactions with competent authorities (e.g. FDA, BfArm, Swissmedic, CCMO) and notified bodies, through regulatory processes such as pre-submissions, breakthrough devices program, De Novo, to facilitate access to future market approval processes (e.g. 510K, PMA, CE marking). • Lead usability and human factors analyses per IEC 62366-1 for Active Implantable Devices and Software as Medical Devices. Printed copies are uncontrolled unless signed by the appropriate authorities - Check you are using the latest version - Page 2 of 2 • Support scientific and regulatory discussions with internal stakeholders within clinical, medical, regulatory, R&D and business development to drive support of the regulatory and clinical strategy, communicate evidence needs for multiple projects. • Provide regulatory support for Risk Management per ISO 14971 activities throughout product lifecycle. • Support clinical investigation and evaluation, literature review with the support of the Field Clinical Research Associate and Contract Research Organization. • Perform post market surveillance, regulatory intelligence with the support of the Regulatory & Clinical Affairs Engineer. • Mentorship of Wyss staff in various disciplines. • Support the clinical and regulatory affairs activities in neurotechnology, neuroimaging and neurobiology projects (good practices). The candidate should be flexible and open to providing quality solutions for neurotechnology applications in a cutting edge, multidisciplinary environment. The candidate must also be able to work independently and propose innovative approaches to quality paths suitable for active implantable medical devices. Required competence and experience: • MS in Biomedical Engineering or relevant Life Science discipline, with 6 to 8 years of experience in a similar position in the medical device industry (preferably with class III implantable medical devices). • Experience interacting with Regulatory Authorities (such as FDA, BfArm, Swissmedic, CCMO) and Notified Bodies. • Detailed understanding of the EU, Swiss and USA medical device regulations, including the MDR 2017/745/EU, MEDDEV 2.7/1 rev 4, FDA 21 CFR Part 820 and ISO 13485 requirements. • Experience or knowledge in one or more of the following areas: – Active implantable or implantable medical devices (e.g. ISO 14708 series, EN 45502-1 series) – Medical device usability engineering – IEC 62366-1 – Medical electrical equipment – IEC 60601 series – Software as a Medical Device – IEC 62304 – Clinical investigation of medical devices for human subjects – ISO 14155 • Previous experience developing strategies to generate clinical evidence is preferred (Clinical Evidence Report). • Very high attention to detail with good verbal and written communication skills. • Strong problem-solving skills, fast learner, enthusiastic, curious, ability to mentor others. • Fluent in English; proficiency in French a plus. Additional competence: • Experience or interest in neuroscience. • End to End Project Management experience, able to manage multiple projects simultaneously. • Statistics and statistical knowledge are a plus. – To apply, please send your CV and cover letter to HRwysscenter.ch.
Regulatory Affairs Manager
Envista, Zürich
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single tooth to fully edentulous indications. We offer dental implant systems, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. We support customers throughout their professional and practice development. Nobel Biocare Headquarters is based in Zurich-Airport, Switzerland, and we have around 34 direct sales organizations worldwide. Nobel Biocare is a member of the Envista Cooperation. To strengthen our Regulatory Affairs Team in Zurich-Kloten we are looking for a Regulatory Affairs Manager The Regulatory Affairs Manager is responsible for regulatory affairs deliverables for design control, compliance projects and lifecycle maintenance activities for the Nobel Biocare portfolio, with a focus on IFU, labeling, regenerative products and UDI. You will be also accountable for delivery of compliant and accurate submission or maintenance of data in international UDI databases. Responsibilities: UDI and Regeneratives Maintain UDI processes (e.g. GUDID) and implement additional countries UDI processes (e.g. EUDAMED), incl. monitoring of legislative UDI and medical device database requirements globally Ensure timely and accurate UDI submissions for new launch projects Provide in-depth knowledge and regulatory input in UDI and RA data governance projects under some guidance, including testing of new IT solutions Support RA processes related to 3rd party regeneratives products, including products for CE, US and CA. Label and IFU Provide regulatory subject matter expertise on global labeling and IFU (including eIFU) regulations Provide in-depth regulatory guidance for Nobel Biocare IFU and labeling processes General: Develop and execute regulatory strategies, ensuring that near misses, nonconformities and lessons learnt are monitored and systems and procedures updated to prevent re-occurrence. Develop and provide, under minimal supervision, regulatory guidance to project teams in terms of premarket requirements and related submission to support optimal timelines and required compliance levels Create, review and maintain technical files. Review and approve of product related labeling and marketing material and associated claims. Assessment, approval and regulatory implementation of change requests under guidance and supervision. Support internal and external audits Creation and maintenance of regulatory procedures and templates under guidance. Provide internal trainings on relevant regulatory procedures and requirements. Support standard committee work including creation of gap analyses. Monitor closely guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets. Job Requirements: A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred. In-depth knowledge of EU, US and CA medical device regulations. Further markets is an advantage and in regards to UDI essential. Knowledge of design control process requirements and requirements for technical documentation for medical devices. Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485 Fluency in English a must. German or further languages is an advantage. Experience in SAP including data handling and Office based programs, especially Excel Minimum 4-5 years experience in regulatory affairs within medical device industry. Good experience in developing, reviewing and assuring required compliance of design control and associating technical documentation. Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
Regulatory Affairs Manager (Wealth Management / Reporting) #184409
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Svizzera-Switzerland - Region Zurich-Zürich |   Tempo pieno | Risk, Legal & Compliance |  ID annuncio  184409Legal & ComplianceEnglish Per saperne di più su Credit Suisse Scoprite di più sulla vita in Credit Suisse Your field of responsibility   An exciting role encompassing the management of interactions between Credit Suisse and Swiss regulatory authorities, especially FINMA as the global lead regulator of the bank. You will manage interactions between regulators and Credit Suisse senior management as a gatekeeper for a broad universe of regulatory topics with a focus on wealth management. As an contact person you influence on the messaging to regulato
Regulatory Affairs Manager Cosmetics
AXEPTA SA, Lausanne, Switzerland
My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Global Regulatory Affairs team in Switzerland, Lausanne area. Due to this growth my client is looking for a Global Regulatory Affairs Manager with experience working on Cosmetics/Medical Devices Products at global level.   Regulatory Affairs Manager Cosmetics     Key deliveries & accountabilities: Setting up the regulatory strategy for projects under development Coordinates the preparation and participates to meetings with Health Authorities/Notified Bodies if necessary Communication of project relevant RA information to Project Team and Department Heads Represents RA for medical devices or cosmetics in global & cross functional meetings Provides regulatory support to ensure the content of dossier/technical files is compliant with relevant regulations and is sufficient for submission Updates Product Information periodically or upon specific request Ensures regulatory support for new product launch Maintains and tracks RA activities databases Supports the development of labelling and artworks   Work Experience: Minimum 4-5 years of prior experience in global Regulatory Affairs in the Consumer Care environment Cosmetics and Medical Devices. PhD (in Sciences, Medicine or Pharmacy), Master or any equivalent advanced scientific degree in a related technical field Strong knowledge of the cosmetic and medical devices industry, including solid knowledge of all associated global RA regulations      
Regulatory Affairs Manager CTA contract
Michael Bailey Associates - Zurich, Switzerland
A new opportunity has been opened for experienced Regulatory Affairs Manager to support busy team with submission for products in the development stage. Major Accountabilities: Responsible for implementing regulatory strategy and managing operational activities for assigned regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. Partners with regions to align on regulatory strategy in order to fulfil business objectives Implements RFP across assigned regions. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to regulatory boards on regulatory strategy. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge. Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL. Represents RA on or leads sub-teams as required. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. 9May lead negotiations for regional approvals independently or with RA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP. Responsible for finalization and on time submission of annual reports and renewals across assigned regions. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with policies and guidelines.Requirements:BS or MS with requisite experience and demonstrated capability. Languages: Fluency in English as a business language. Strong knowledge of regulatory submission and approval processes in 1 or more major regions. Experience leading regulatory submissions and approvals in at least 1 major region. Experience in a global/Matrix environment or cross- functional teams in the pharmaceutical industry Experience in HA negotiations. regulatory and drug/biologic development spanning activities in Phases I-IV Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Regulatory Affairs Manager
Swisslinx, Basel, Switzerland
For our client, a biotech company, Swisslinx is looking for a Regulatory Affairs Manager to support clinical trial and product license applications for various CMC biological projects for customers. This is a Full time position that can be located either in Basel or Visp. The contract duration is 12 months. Your Mission: - Author/review and provide input from a CMC perspective on relevant documents required for (BLA/MAA) submission for Biologicals - Author/review the Module 3 section for IND/IMPD for biologicals - Facilitated and/or attended CMC meetings with key stakeholders and regulators when applicable (eg FDA/EMA) for biologicals - Provide regulatory advice to customers for biological projects - Provide regulatory support for projects and project teams - Prepare briefing documents for agency meetings - Attend customer meetings and project team meetings - Devise and maintain regulatory project plans in line with the best practice recommendations - Update functional leads and maintain transparency of information across regulatory function - Site support activities, eg perform assessments for change controls and deviations; support site specific regulatory documents Your Profile: - Master or Bachelor degree in Life Sciences (eg Biology, Biochemistry, Pharmacy) or above - Experience (at least 5 years) in preparing and authoring CMC (Chemistry, Manufacturing and Control) sections for regulatory documents through product life cycle - Good understanding of regulatory requirements for biologicals - Good practical experiences in Regulatory Affairs in a pharmaceutical environment - Previous experience in CMO/CDMO environment is a clear advantage - Fluent in English required; German is a plus If you hold the skills above, don't hesitate to click apply now or send your CV on (see below) By applying for this position, I consent to the Swisslinx Group of companies: - storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external Servers for the purpose of informing me of potential employment opportunities - using my personal information or - supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities - transferring where applicable my personal information to a country outside the EEA/EFTA I also hereby agree to the Swisslinx privacy policy
Regulatory Affairs Manager
Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran – acquired by Capgemini in 2020 - and Capgemini's digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotiv