Regulatory Affairs Manager

vor 2 Wochen


Zug, Schweiz Bioeq AG Vollzeit

About Bioeq
Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and
Formycon and is based in Zug. We license, develop and commercialise a biosimilar, which is a
successor product of Lucentis® (ranibizumab), a successful branded biopharmaceutical. We are a
young and dynamic company, supported by an international network of experts. Bioeq AG out-licenses
its products to established international pharmaceutical companies who ensure local distribution in each
territory.
About the role
You will act as Technical Regulatory Affairs Manager and maintain the Technical Regulatory System
and its compliance with applicable regulatory requirements in the different countries and also be
responsible for the medical device compliance activities. Your main activities will be:

- Maintain the approved dossiers of the lifecycle of the products
- Ensure that Regulatory procedures and records with respect to CMC / Quality are in

compliance with applicable regulations and standards
- Prepare administrative documentation on time and Module 1 documentation for

regulatory submissions / variations as well as provides support to CMC writing for initial
MA submission in various regions. Ensure that regulatory variations are accurate and
verifiable against source documents to confirm compliance and traceability
- Prepare submissions for new markets
- Participate in expert discussions with different stakeholders’ prior approval and support

by answering questions during the approval process
- Maintain the Quality System for Regulatory Activities
- Collaborate closely with external service providers (e.g. publisher or CMC writing) on

Regulatory Affairs aspects
- Support Senior Management and Line Manager in all Regulatory Affairs aspects
- Collaborate with Regulatory Affairs functions within and outside of the company
- Interact with Health Authorities on Regulatory Affairs aspects of the company
- Manage Change control system and coordinate information to all relevant stakeholders

on time
- Assure post marketing surveillance regarding pharmaceutical legislation and guidance in

Switzerland
About you
You have a cooperative, self-motivated and pro-active mindset. You combine excellent planning and
execution skills with the ability to work effectively in international matrix organisations. Furthermore, you

**possess the following qualifications**:

- University degree / state examination in pharmacy or other natural sciences
- Proven track record of 7+ years in the pharmaceutical industry in Life Cycle Management

internationally with at least 5 years of GMP/GDP experience in a regulatory function,
preferably as Regulatory Affairs Manager
- Experience of working in different regulatory regions
- Sound knowledge of EU, US and CH GMP/GDP regulations, in quality system requirements,

as well as from biopharmaceuticals
- Good knowledge of eCTD structure and its compilation

lifecycle
- Fluent in English and German

How to connect



  • Zug, Schweiz Swisslinx Vollzeit

    Our client, a leading pharmaceutical company based in the area of Zug is searching for a Regulatory Affairs Manager. It's on offer a 2 years contract with highly potential extension. Your mission: - Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for...


  • Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager (LSW) - RZ for a pharmaceutical establishment. This role is on a contract basis and is located in Zug with hybrid working available. The client is focused on supplying novel solutions for various illnesses. **Responsibilities**: - Accountable for upkeep of product technical files and for current...


  • Zug, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Regulatory Affairs Manager. **Background**: **Tasks & Responsibilities**: - Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for...


  • Zug, Schweiz Talentor Sweden AB Vollzeit

    In this role you will manage activities associated with regulatory approval of** in vitro diagnostic medical device**s. You will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Additionally, you are responsible for assessment of device changes for regulatory...


  • Zug, Schweiz Viatris Vollzeit

    7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...


  • Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Project Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Zug. *** **Responsibilities**: - Handle regulatory duties affiliated with the development, assistance, and deployment of the company's non-medical and medical device software products. - Supervise and examine both...


  • Zug, Schweiz BioTalent Vollzeit

    **Snr Director Regulatory - Contract**: In collaboration with a well funded fast paced BioTech, BioTalent are looking to connect a seasoned Regulatory Industry professional to fulfil EU and UK requirements in alignment with the Global Team. This role will offer you - 3-6 month rolling contract - Ability to work part time - Hourly pay rate - Remote...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    Title**:Medical Affairs Coordinator** Location(s): Zug, Switzerland Level of position: Senior Specialist Position type: office-based, in alignment with BlueFlex model* Reporting Line: The position reports to the Associate Director, International Medical Affairs **How will your role help us transform hope into reality?** This position reports into the...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: UK - London - Brentford, Baar Onyx, Switzerland - Zug, USA - Pennsylvania - Upper Providence **Posted Date**: Apr 4 2024 **Medical Director, Global Medical Affairs - Hematology**: The Global Medical Director role is a unique opportunity for an experienced, innovative, and proactive medical professional to facilitate the understanding of the...


  • Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. **Responsibilities **_(including, but not limited to)_**: - Ensure continuous supply of clinical trial material for assigned studies globally - Ensure on-time startup of new studies by having supplies available as...


  • Zug, Schweiz WWZ Energie AG Vollzeit

    Das sind deine Aufgaben: Du verantwortest regulatorische Fragestellungen im Rahmen der Strom- und Gasversorgungsgesetzgebung und verfolgst die politische und regulatorische Entwicklung Aus deinen Analysen leitest du Handlungsempfehlungen ab, erstellst Risikobewertungen und unterstützt so die Strategiedefinition von WWZ  Bei der politischen Positionierung...

  • Medical Manager

    Vor 3 Tagen


    Zug, Schweiz IPSEN Vollzeit

    **Title**: Medical Manager / Medical Scientific Liaison Manager - Oncology(M/F/d) **Company**: IPSEN Pharma Schweiz GmbH Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and...


  • Zug, Schweiz Pfizer Vollzeit

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Investment Manager

    Gefunden in: beBee S CH - vor 3 Wochen


    Zug, Schweiz Green Recruitment Company Vollzeit

    ​As an Investment Manager specializing in the renewable energy sector, you will be responsible for managing the end-to-end investment process, from sourcing and evaluating investment opportunities to executing deals and overseeing portfolio performance.​The Role:Identify and assess potential investment opportunities in the renewable energy space,...

  • Chief of Staff

    Vor 3 Tagen


    Zug, Schweiz MoonLake Immunotherapeutics Vollzeit

    **Job Purpose**: The The Chief of Staff - Clinical Development serves as the primary strategic partner and advisor to the CSO and other members of the Executive Board if needed (CEO and CFO). Their mission is to optimize operational efficiency, drive strategic decision-making and implementation of organizational goals and initiatives in the Clinical...

  • Process Support Engineer

    Gefunden in: beBee jobs CH - Vor 4 Tagen


    Zug, Zug, Schweiz Talentor Switzerland Vollzeit

    start date: end date: one year contract, with a high chance on extensionworkload: %location: Rotkreuz (CH)work model: Contracting Your Responsibilities:Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management, Verification...

  • Process Support Engineer

    Gefunden in: beBee S CH - Vor 4 Tagen


    Zug, Schweiz Talentor Switzerland Vollzeit

    start date: 01.06.2024end date: one year contract, with a high chance on extensionworkload: 80 - 100%location: Rotkreuz (CH)work model: Contracting Your Responsibilities:Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration...


  • Zug, Schweiz BioTalent Vollzeit

    I have an excellent opportunity for a highly motivated and skilled **Senior Commercial Insights & Operations Manager** to join a dynamic team in the international division of a leading biopharmaceutical company based in **Zug, Switzerland**, who are focussed on discovering, developing, and commercialising revolutionary medicines that significantly improve...

  • Trading associate

    Gefunden in: Jooble CH O C2 - Vor 4 Tagen


    Zug ZG, Schweiz Merck Group Vollzeit

    In a global team of trade compliance specialists spanning different countries and cultures, the role involves ensuring compliant trade at our Swiss site in Buchs, in line with all relevant trade compliance regulations. Responsibilities include overseeing transactional processes related to regulated product orders, conducting internal and external audits,...

  • Product Manager Platform

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz SHL Group Vollzeit

    Job Overview The Product Manager Platform is the glue between the business side and technical side of an organization. She/he has a deep understanding what technology is required to meet the business requirements and how to successfully bring a product to life and manage it through its entire commercial life cycle. To reach this goal the product...