Regulatory Affairs Manager

Vor 2 Tagen

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 actions linked to compliance with international regulatory directives and guidelines.
- Handle the production and evaluation of SOPs and policy regulations for the regulatory affairs division.
- You might offer consultative and training assistance to the business unit and core regulatory staff connected to premarket proposals, product labelling and multifaceted proposals concerns.
- When suitable, you will interface with regulatory authorities on regulatory and technical issues.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a science, engineering or similar discipline.
- A certification in regulatory affairs would be ideal.
- At least 3-5 years of experience in a regulatory, development, clinical affairs, quality, or program management role within an IVD, medical device, or pharma organisation.
- Familiarity with regulatory proposals which involves IDE, 510(k), and PMA proposals would be ideal.
- Past involvement in CDx with proposals for IND, NDA/BLA or pharma.
- An organised individual with a high attention to detail.
- Communication skills both verbally and in writing.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-AY1

Regulatory

  • Regulatory Affairs Manager

    vor 2 Stunden

    Zug, Zug, Schweiz Randstad Switzerland Vollzeit

    For our client, a leading biotechnology company based in canton Zug, we are seeking aRegulatory Affairs Manager.General Information:Start date: ASAPEnd date: 30/06/2026Contract: temporary contract via RandstadWorkplace: Baar, ZugWorkload: 100%Working hours: StandardTask & Responsibilities:Responsible for managing the development and implementation of...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zug, Zug, Schweiz Merck KGaA Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zug, Zug, Schweiz Merck Healthcare Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Head of Regulatory Affairs, Europe

    vor 4 Wochen

    Zug, Schweiz Scholar Rock Vollzeit

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life‑changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

  • Head of Regulatory Affairs, Europe

    vor 1 Woche

    Zug, Zug, Schweiz Scholar Rock Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

  • Drug Regulatory Affairs Manager

    vor 1 Woche

    Zug, Schweiz nemensis ag Vollzeit

    At nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Rotkreuz, we are looking for a Drug Regulatory Affairs Manager. **Job Purpose**: Takes care of all drug regulatory affairs matters regarding the...

  • Regulatory Affairs Pediatrics Director

    vor 2 Wochen

    Zug, Zug, Schweiz Actalent Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    On behalf of our client, we are currently seeking a Regulatory Affairs Director – Pediatrics for a 50% contract position, fully remote, with the requirement to be based in Switzerland.*Please note that we can only consider EU/Schengen applications, or valid Swiss permitResponsibilities:Develops and implements the EU/US and relevant international regulatory...

  • Associate Director Regulatory Affairs EMEA

    vor 2 Wochen

    Zug, Zug, Schweiz AurigaVision AG Vollzeit CHF 100'000 - CHF 150'000 pro Jahr

    For our globally active client, a well-established and innovative biopharmaceutical company with approved products and a very exciting pipeline of novel therapies (pulmonary indications), we are looking for an:Associate Director Regulatory Affairs EMEA (Ref. 2522)ZugAs Associate Director Regulatory Affairs, you will be responsible for commercial Regulatory...

  • Director, Regulatory Affairs CMC

    vor 1 Woche

    Zug, Zug, Schweiz Cytokinetics Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Director, Regulatory Affairs CMC

    vor 1 Woche

    Zug, Zug, Schweiz Cytokinetics Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...