Global Regulatory Affairs Manager

vor 1 Tag


Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Regulatory Affairs organization based at our Headquarters in Lausanne, we are looking for a

Global Regulatory Affairs Manager

Working in a matrix environment, you will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and radiopharmaceuticals. You will contribute with technical and operational expertise to the implementation of regulatory strategies. Additionally, you will ensure compliance to applicable regulations and relevant processes when performing assigned tasks.

**Your responsibilities will be but not limited to**:
Support a RA senior professional for the development and implementation of the global RA strategy for assigned projects,
Participate in the management of external vendors such as CROs
Contribute to the preparation and tracking of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc.
Represent RA in cross-functional sub-teams, such as Clinical Study Teams
Participate in the review of documents of regulatory relevance such as Clinical Study Reports, DSURs, etc.
Work closely with functional experts to coordinate their contributions to regulatory documents
Maintain knowledge of global competitive and regulatory landscape and contribute to the assessment of the impact changes might have on assigned projects
Contribute to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations
**Requirements**:
Bachelor’s or Master’s degree in life-sciences, combined with at least 3 years of regulatory affairs experience in the field of drug development, including experience in managing clinical trials
You gained strong understanding of regulatory procedures in the EU and/or US
Knowledge of products in Oncology is an asset
You demonstrated excellent organizational, communication and time management skills needed to manage multiple ongoing tasks/projects simultaneously
You have strong analytical skills with a solution driven mindset
You are Independent, results driven and team-oriented, advocating the cross-functional collaboration
You are fluent in English (oral and written), French is an asset

**Benefits**:
International, highly dynamic environment with a long term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.



  • Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...


  • Lausanne, Schweiz Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...


  • Lausanne et environ, Schweiz Manpower Vollzeit

    Key Responsibilities Core Activities: Lead regulatory activities for NPD projects and sustaining operations, including preparing, coordinating, and maintaining EU Medical Device dossiers, CE Mark submissions, and Technical Documentation, ensuring alignment with EU regulations. Serve as the primary liaison with Notified Bodies, presenting regulatory...


  • Lausanne, Schweiz Centre hospitalier universitaire vaudois Vollzeit

    **Contexte**: The Lausanne University Hospital (CHUV) is one of five Swiss university hospitals. Through its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the EPFL, CHUV plays a leading role in the areas of medical care, medical research and training. The SCTO has set up a national network of thematic expertise...


  • Lausanne, Schweiz Centre hospitalier universitaire vaudois Vollzeit

    **Contexte**: The Lausanne University Hospital (CHUV) is one of five Swiss university hospitals. Through its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the EPFL, CHUV plays a leading role in the areas of medical care, medical research and training. Member of the network of the Swiss Clinical Trial Organization...

  • Regulatory Strategy Lead

    vor 2 Monaten


    Lausanne, Schweiz ALTOGEN AG Vollzeit

    ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...


  • Lausanne, Schweiz Nestle Vollzeit

    Nestlé Health Science was created in 2011 by Nestlé, the leading food and beverage company. We are a unique health science company focused on advancing the role nutrition plays in changing the course of health for consumers, patients and healthcare professionals. Focused on delivering quality-of-life benefits through nutritional solutions, we harness...

  • Public Policy

    vor 7 Monaten


    Lausanne, Schweiz Philip Morris International Vollzeit

    PMI is seeking a motivated and detail-oriented intern to support our Public Policy & Economic Research, and Public Affairs teams. This internship provides a unique opportunity to gain hands-on experience in the dynamic field of Public Policy & Economic Research as well as the Public Affairs fields. The internship will be equally split between the two...


  • Lausanne, Schweiz Nestle Vollzeit

    Nestlé Health Science is a globally recognized leader in the science of nutrition, with more than 11,000 employees around the world. With a portfolio of science-based consumer health, medical nutrition, vitamin and supplement brands, and pharmaceutical therapies, we are redefining the management of health **Position Snapshot**: Position Snapshot Location:...


  • Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery...


  • Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery...


  • Lausanne, Schweiz Keurig Dr Pepper Vollzeit

    Job Overview: **Purpose**: This role is responsible for managing the outbound and sea freight logistics and relations for our international green coffee logistics operations. The role will be varied as outlined under responsibilities below, but this person will oversee supply chain logistics-related activities as it applies to global green coffee purchasing....

  • Capex Project Manager

    vor 7 Monaten


    Lausanne, Schweiz Capgemini Engineering Vollzeit

    **About Us**: At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • Capex Project Manager

    vor 7 Monaten


    Lausanne, Schweiz Capgemini Engineering Vollzeit

    **About Us**: **At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...


  • Lausanne, Schweiz Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...


  • Lausanne, Schweiz Unilabs Switzerland Vollzeit

    IntroductionUnilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.Your TasksPromote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance...


  • Lausanne, Schweiz Unilabs Group Services Vollzeit

    Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.Your TasksPromote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance with ISO...


  • Lausanne, Schweiz VCLS Vollzeit

    **Director Regulatory Science** This role will afford you the opportunity to have an immediate impact locally with our Swiss team and clients and to develop professionally by providing exposure to global projects and a diverse portfolio of client products. **Role overview** - Provide expert advice and guidance to clients on regulatory matters, with a focus...


  • Lausanne, Schweiz LHH Vollzeit

    **Global Supply Chain Quality Manager - Based in Western Switzerland** - Support the development, execution, and delivery of global s**upply chain quality **strategies for the company. Partner with Quality Site Heads, Global Quality Functions, R&D, **Supply Chain**, Operations & Marketing to assure** Global Supply Chain **Objectives are identified and...

  • Global Market Access

    vor 7 Monaten


    Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit

    **Position Snapshot** Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Type of contract: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could look like for...