Regulatory Affairs Consultant
vor 3 Monaten
Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team
**Key Responsibilities**:
- Provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland
- Support national dossier filings and contribute to centralized dossier preparation
- Lead small-scale projects or work streams, ensuring client satisfaction and project success
- Collaborate with cross-functional teams to deliver high-quality regulatory solutions
- University degree in a scientific area
- Several years of experience in regulatory affairs, specifically in German and Swiss markets
- Experience working with Swissmedic and BfArM
- In-depth knowledge of international regulatory requirements
- Strong understanding of EU regulatory landscape
- Excellent project management and client communication skills
- Ability to work independently and as part of a team
- Proactive problem-solver with keen attention to detail
- Fluent English and German speaker (required)
LI-REMOTE
Back to nav
-
Director of Regulatory Affairs Eu
vor 6 Monaten
Home Office, Schweiz PTC THERAPEUTICS VollzeitJob Description Summary: Founded in 1998, PTC Therapeutics is a global biopharmaceutical company focused on discovery, development and commercialization of innovative treatments that bring benefits to patients suffering from rare diseases. For more than 25 years, PTC have been harnessing its scientific platforms to deliver a number of life-changing...
-
Regulatory Affairs Scientific Leader
vor 6 Monaten
Home Office, Schweiz Dechra Pharmaceuticals PLC VollzeitJob Introduction Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC. Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. Here...
-
Associate Director, Regulatory Cmc
vor 2 Monaten
Home Office, Schweiz Apellis Pharmaceuticals Vollzeit**Position Summary**: We are looking for an** Associate Director, Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) **to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to provide regulatory CMC support for the development and commercialization of our products. This position will be...
-
Director, Regulatory Information Management
vor 6 Monaten
Home Office, Schweiz BeiGene VollzeitGeneral Description: The Director, RIM is responsible for partnering with internal and external stakeholders in executing the RIM strategy and vision for the organization. This includes activities related to RIM resources, planning and budgeting (in partnership with IT), for key systems implementation/upgrade, monitoring and analysis of submission and...
-
Mgr, Regulatory Intelligence
vor 7 Monaten
Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit**Description** **JOB SUMMARY**: The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities...
-
Sr Biostatistician
vor 6 Monaten
Home Office, Schweiz Syneos Health Clinical Vollzeit**Description** **Medical Affairs - Senior Biostatistician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...
-
Director Process Engineering
vor 6 Monaten
Home Office, Schweiz Summit Therapeutics Sub, Inc. Vollzeit**Job Title: Director, Process Engineering** **Location: Switzerland (Remote)** **Our Mission**: **Summit Activities**: We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with...
-
Project Manager/ Consultant
vor 6 Monaten
Home Office, Schweiz Procivis AG VollzeitProcivis AG is a leading Swiss provider of decentralized digital identity and credential solutions. We build software for seamless identity integration into any process with a modular end to end solution. Founded in 2016, we offer solutions to multiple clients. Since 2021, we have been a subsidiary of Orell Füssli, a globally renowned company for security...
-
Cco - Life Sciences Consultancy
vor 4 Monaten
Home Office, Schweiz Luminary Group VollzeitLuminary Group is currently seeking a highly experienced and strategic-minded Chief Commercial Officer to join our client. As the Chief Commercial Officer, you will play a critical role in driving the commercial success of our life science consulting business, focusing on regulatory affairs (RA), pharmacovigilance (PV), quality assurance (QA), and...
-
Single Sponsor Principal/sr Medical Writer
Vor 7 Tagen
Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit**Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
-
Single Sponsor Principal/sr Medical Writer
Vor 7 Tagen
Home Office, Schweiz Syneos Health Commercial Solutions Vollzeit**Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
-
Consultant (Home-based) - Mentor
vor 2 Monaten
Home Office, Schweiz UNITAR VollzeitDuration of the contract - 4 months - 28 October 2024 - Organizational Unit - Hiroshima Office (HO) - Number of job positions - 1 - Area of Specialization/Thematic Areas Career counseling, human resources management, peacebuilding and international development - Overview (quick description of the funded project and its context) The United Nations Institute...
-
Medicine Development Leader
vor 6 Monaten
Home Office, Schweiz Sobi Vollzeit**Role & Function** The Medicine Development Leader has the overall responsibility for bringing and representing the clinical and the medical strategy for the assigned product to the Core Asset Team (CAT), including benefit / risk evaluation, PV and Safety. **Key Responsibilities** - Provides medical and scientific expertise and perspective to inform asset...
-
Sr Clinical Supplies Manager
vor 6 Monaten
Home Office, Schweiz Summit Therapeutics Sub, Inc. Vollzeit**Job Title: Sr Clinical Supplies Manager** **Location: Switzerland** **Our Mission**: **Summit Activities**: We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF...
-
Home Office, Schweiz International Telecommunication Union (ITU) VollzeitINTERNATIONAL TELECOMMUNICATION UNION - ITU is the leading United Nations agency for information and communication technologies, with the mission to connect the world. To achieve this, ITU manages the radio-frequency spectrum and satellite orbits at the international level, works to improve communication infrastructure in the developing world, and...
-
Consultant in Esg Frameworks and Sustainability
vor 7 Monaten
Home Office, Schweiz dss+ Vollzeit**The role** As a Consultant, your primary mission is to engage in projects that advise decision-makers on their Sustainability journey, employing robust impact-driven and science-based methodologies, ESG frameworks, and metrics, while considering the business and stakeholder context. Your responsibilities will include providing strategic advice to clients...
-
Principal Advisor
vor 1 Monat
Home Office, Schweiz Axmed VollzeitWe are seeking a highly experienced Principal Advisor - Post-Launch Strategy & Market Expansion to lead the development of a robust go-to-market strategy of a few new pharmaceutical products, focusing on Low - and Middle-Income Countries (LMICs), with a particular focus on post-commercialization milestones, including marketing strategy, medical affairs and...
-
Medical Science Liaison
vor 6 Monaten
Home Office, Schweiz Argenx VollzeitJoin argenx At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you. Next to a competitive salary with extensive benefits, we...
-
Sponsor Dedicated Principal Medical Writer
vor 6 Monaten
Home Office, Schweiz Syneos Health Clinical VollzeitDescription Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we...
-
Cybersecurity Consultant
vor 6 Monaten
Home Office, Schweiz UNICC Vollzeit**Background information** The High Level Committee on Management (HLCM) of the UN formally adopted the Principles on Personal Data Protection and Privacy at its 36th Meeting on 11 October 2018. These principles set out a basic framework for processing “personal data”, defined as information relating to an identified or identifiable natural person, by...