Gehaltsübersicht für Regulatory Affairs in Schweiz
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Gehaltsübersicht für Regulatory Affairs in Schweiz
120 000 ₣ Durchschnittliches Monatsgehalt
Durchschnittliches Gehaltsniveau in den letzten 12 Monaten: "Regulatory Affairs in Schweiz"
Das Balkendiagramm zeigt die Änderung des Gehaltsniveaus in der Regulatory Affairs Branche in Schweiz
Verteilung des Stellenangebots "Regulatory Affairs" in Schweiz
Wie die Grafik zeigt, in Schweiz gilt Graubünden als die Region mit der größten Zahl der offenen Stellen in und an zweiter Stelle folgt Basel-Stadt. Den dritten Platz nimmt Kanton Waadt ein.
Ranking der ähnlichen Stellenangebote gemäß dem Gehaltsniveau in Schweiz
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.
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 Specialist
Randstad (Schweiz) AG, Oberdorf
Do you want to work in a medical device company ? Do you have at least 4 years experience in Regulatory Affairs ? You should then read the following lines!Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission until the end of the year with strong possibility for extension OVERALL RESPONSIBILITIES:Support MDR compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices to comply with MDR requirements POSITION DUTIES & RESPONSIBILITIES:• Identify, create and/or update reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Table of Contents, Declaration of Conformity, and labeling.• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.• As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.• Identify and adhere to policies, procedures and work instructions which support technical documentation activities• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials• Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan• Support for routing and implementation of the remediated documents in PLM systems• Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required• Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations EXTENDED DUTIES:• Follow the quality standards and regulatory requirements• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times• Resolving complex issues as they arise PROFESSIONAL EXPERIENCE REQUIREMENTS:• At least 5 years of experience in European Medical device as regulatory affairs specialist• Strong knowledge of ISO 13485 and ISO 9001, QSR,• understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)• MEDDEV guidance documents applicable to Medical Devices products and processes• Strong understanding of Risk Management process, label and labeling, change management is desired EDUCATIONAL REQUIREMENTS:• Master’s Degree in engineering or life sciences is required; LANGUAGE:• English fluent is mandatory (all documentation in English) OTHER REQUIREMENTS:• Strong knowledge and skills in MS Office• Familiarity with Technical Documentation structure according to STED required• Strong interpersonal and diplomatic skills• Team work oriented, within a multi-functional and multi-national team• Customer / service orientation• High analytical, planning and organizational skills; able to set priorities Do not waste any minutes, apply now! We are looking forward to receiving your application.
Regulatory Affairs CTA Manager
Michael Page, Zürich
Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments in the Europe (EU, UK (post-Brexit) and Switzerland). Support for rest-of-the-world clinical trial applications may be requiredContribute to the regulatory strategy by bringing the European insights into discussionsInteract with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal productsWork with regulatory affairs consultants/service providers on CTA submissions Represent EU Regulatory Affairs at cross-functional study management team meetingsAnticipate and bring solutions for potential regulatory risksMaintain good knowledge of regulatory requirements and guidelinesResearch relevant regulatory precedents to understand the regulatory landscape applicable to development programsCommunicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscapeParticipate in process improvement initiatives as requiredMaintain an effective archiving and submissions/approvals tracking recordsSupport the European Regulatory team as required.Minimum Requirements:Minimum of 4 years of experience managing regulatory submissions, with a primary focus on clinical trial applications and associated tasksBSc; MSc or PhD in a life sciences disciplineFluent in English (written and spoken)Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European UnionKnowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage).Competencies And AttributesExcellent oral and written communication skills for effectively interfacing with all levels of management and departments within the companyStrong technical/analytical skills to identify and solve problems independentlyProven ability to manage multiple projects, identify and resolve regulatory issuesAbility to balance regulatory objectives with business objectivesWillingness to work collaboratively and incorporate diverse perspectives into decision-makingSelf-motivated, assertive, and self-confident with the ability to act with urgency and passionStrong organizational skills in order to maintain a high level of productivity, innovation, and priority-settingAbility to work under pressure, meeting time sensitive deadlines, while maintaining a high level of qualityProactively seeks out and recommends process improvementsEntrepreneurial, enjoys working in a fast-paced, small-company environment
Regulatory Affairs Associate Director, Europe
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: The Regulatory Affairs Associate Director/Director will be responsible for developing and implementing EU, UK and Swiss regulatory strategies for development programs to secure and maintain the marketing authorization for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of desi
Regulatory Affairs CMC Senior Manager
Randstad (Schweiz) AG, Basel
Do you want to work in a big pharmaceutical company? Do you have some experience in RA CMC? You should then read the following lines! Our client, based in Basel, is looking for a Regulatory Affairs CMC Senior Manager for a mission until december 2022. Job Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. Major Activities: 1.Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.4.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.7.Establish and maintain sound working relationships with partners and customers.8.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). Ideal Background:- Education (minimum/desirable):Minimum:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable:Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. - Languages: Fluent English required (oral and written).Good skills in site (local) language desired (oral) - Experience/Professional requirement:1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals2.Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.5.Effective planning, organizational and interpersonal skills.6.Reasonable approach to risk assessment.7.Excellent written/spoken communication and negotiation skills.8.Computer literacy. Do not waste any minutes, apply now! We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
Sysmex Suisse AG, Horgen
Als Produzent und Vertriebsorganisation im medizinischen Bereich unterliegen wir verschiedenen Gesetzen und Regulatorien und müssen unterschiedliche Standards einhalten. Die Abteilung Regulatory Affairs stellt sicher, dass diese Auflagen jederzeit vollumfänglich eingehalten werden. Ein Schwerpunktthema in der Abteilung Regulatory Affairs bildet die Produktsicherheit durch sicheres Design und die entsprechenden Vorsichts- oder Schutzmassnahmen. Darüber hinaus weisen wir unsere Kunden durch die entsprechenden Warnkennzeichnungen unserer Geräte, Software-Anwendungen, Reagenzien, Kontrollmaterialien und Kalibratoren auf Sicherheitsrisiken hin. Selbstverständlich erfüllen wir alle Auflagen, die die Sicherheit und den Gesundheitsschutz am Arbeitsplatz, die Umweltschutzvorgaben oder Umweltziele betreffen. Damit wir sowohl alle Auflagen als auch Qualitätsansprüche jederzeit vollumfänglich erfüllen können, müssen wir die Entwicklungen im Markt aktiv beobachten. Durch unsere Mitgliedschaft in der European Diagnostic Manufacturers Association (EDMA) und dem Schweizerischen Verband der Diagnostica- und Diagnostica-Geräte-Industrie (SVDI) sind wir stets aktuell informiert. Rechtsangelegenheiten Unser Team Legal Affairs gestaltet und prüft die Verträge mit unseren Geschäftspartnern. Sie bilden die Basis für eine langfristige und partnerschaftliche Zusammenarbeit. Dabei werden zu jeder Zeit alle Aspekte des Kartellrechts und der Antikorruptionsgesetze berücksichtigt. Der Datenschutz ist eine der Kernaufgaben der Abteilung Legal Affairs. In einer schnell wachsenden Informationsgesellschaft und ihren unzähligen technischen Möglichkeiten des Datenaustausches kommt dem Schutz der personenbezogenen Daten der Patienten besondere Priorität zu. Durch entsprechende Vertragsbestimmungen, sichere Technologien und Zugriffsbeschränkungen gewährleisten wir diesen Schutz. Die Produktzulassungen – eine unabdingbare Voraussetzung für den Vertrieb unserer Systeme und Lösungen – gehören in den Zuständigkeitsbereich unseres Teams Legal Affairs. Die Registrierung und Zulassung von Chemikalien durch die Europäischen Chemikalienagentur (ECHA) gehören ebenfalls dazu.
Regulatory Affairs Specialist Switzerland
DePuy Synthes, part of Johnson & Johnson Medical devices, is recruiting for a Regulatory Affairs Specialist, located in Switzerland, or Germany. The contract will be limited in time with the possibility to be extended. In this role, you will be carrying out regulatory affairs activities needed to follow the requirements of the Swiss Medical Device ordinance. You will gather, prepare and upload regulatory documentation for registrations/notifications of medical devices and Economic Operators in Switzerland. Besides this, you will also support HMD Swiss Authorized representative activities. Support other local regulatory affairs activities as directed. This role is a brand-new position
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 CMC Associate Manager
RM IT Professional Resources AG, Basel, Switzerland
Regulatory Affairs CMC Associate Manager vacancy for a globally operating Basel based company in the pharmaceutical sector. Your experience/skills:Regulatory experience combined with experience in drug or biopharmaceuticals is preferredWorking knowledge of chemistry or biotechnology, analytics or pharmaceutical technologyAbility to critically evaluate data from a broad range of scientific disciplinesA thorough understanding of regulations, guidelines for NCEs and product life cycle maintenance as well as know-how of the drug development process is desirableDegree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology or equivalentLanguages: English, fluent in written and spoken, German is beneficialYour tasks:Authoring high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliancePreparing CMC responses to health authority questions during development, registration and product life cycleIdentifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelinesAnalyzing content, quality or timeliness issues with source documents, or any other potential authoring issuesContributing to the regulatory strategy, identifying the critical issues and lessons learnedStart: 11/2021 Duration: 12MM+ Location: Basel, Switzerland Ref.Nr.: BH17642 Does this Spark your interest? Then take the next step by sending us your CV and a contact telephone number on which you are reachable during working hours. Going the Extra Mile. As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day. Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland. New to Switzerland? In case of a successful placement, we support you with:All administrative questionsFinding an apartmentHealth - and social insuranceWork permit and much moreThank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.