Senior Manager – CMC Dossier Manager
Vor 2 Tagen
Location : Basel, Switzerland
Who is Aixial Group ?
Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.
Since 2014, we have been part of the Alten family.
We are developing our activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.
Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…
Aixial Group
-
Cmc Dossier Manager
Vor 3 Tagen
Basel, Schweiz Sobi Vollzeit**CMC Dossier Manager** The CMC Dossier Manager works in the Sobi Technical Operations Department within in the CMC Program Management unit. The role is responsible for technical oversight and the coordination of generation of CMC documentation. Within the scope is the source documentation for process development, process validation, GMP and non-GMP...
-
Regulatory Affairs Manager
Vor 7 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...
-
Regulatory Affairs Manager
Vor 7 Tagen
Basel, Schweiz Thermo Fisher Scientific VollzeitCMC Expert - Client Dedicated (Regulatory CMC - Biologics) We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we...
-
Sr. Manager, Cmc Regulatory Science
Vor 4 Tagen
Basel, Schweiz Moderna Vollzeit**The Role**: **Here’s What You’ll Do**: Develop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide guidance for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Contribute...
-
Senior Process Manager
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Sobi VollzeitCompany OverviewSobi is an international pharmaceutical company focused on specialty pharmaceuticals. We cater to the high medical needs of rare disease patients and provide treatment and services to them.Job DescriptionWe are seeking a Senior Process Manager to join our team. As a key member of our Global CMC, Science & Technology Department, you will be...
-
Senior Manager – CMC Dossier Manager
vor 1 Tag
Basel, Schweiz TN Switzerland VollzeitClient:Aixial GroupLocation:Job Category:OtherJob Reference:90452fb773fdJob Views:10Posted:24.01.2025Job Description:Who is Aixial Group?Aixial Group is a CRO (Clinical Research Organization) specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post-market.Since 2014, we have been...
-
Sr. Manager, Cmc Regulatory Science
Vor 7 Tagen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: **Here’s What You’ll Do**: Develop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide guidance for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Contribute...
-
Sr. Manager International Operations
Vor 5 Tagen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: This role is an exciting opportunity to be part of a growing CMC international organization, responsible for the manufacturing and supply of Moderna’s COVID mRNA vaccine internationally, as well as preparation for commercial manufacturing for further projects coming via our pipeline. Reporting to the Director, International Operations, the...
-
Senior Recruitment Manager
vor 1 Woche
Basel, Schweiz Randstad Enterprise VollzeitSenior Recruitment Manager (Senior Operations Manager) Be among the first 25 applicants Randstad Sourceright, where technology innovation and our exceptional human touch make us the market leader in Global Recruitment Outsourcing. We operate in 70 countries, across 360 RPO programmes and more than 800 managed services programmes. We create value by combining...
-
Manager, Regulatory Affairs
Vor 5 Tagen
Basel, Schweiz Lonza VollzeitTitle: Manager, Regulatory Affairs (CMC)Hybrid working pattern: 2 WFHLocation: Basel or VispRelocation support is provided – subject to criteria.Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working...
-
Ra Cmc Associate Director
Vor 6 Tagen
Basel, Schweiz Novartis Vollzeit576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives, and we need your help. As a senior member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and...
-
Ra Manager
vor 1 Woche
Basel, Schweiz Proclinical Staffing VollzeitProclinical is seeking a Regulatory Affairs Manager to join our client's team in Basel, Switzerland. This role focuses on supporting regulatory submissions for biological medicinal products within the dermatology sector. You will play a crucial role in ensuring compliance and facilitating communication with health authorities. Please note that to be...
-
Regulatory Affairs Manager
Vor 2 Tagen
Basel, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Responsibilities:Author and review CTD module 3.2 sections (drug substance/ drug product) for biological medicinal products;Prepare high-quality clinical trials applications, BLA/ MAA, and post-approval submissions;Manage timely responses to Health Authority (HA) questions;Lead and coordinate activities to ensure...
-
Regulatory Affairs Manager
Vor 5 Tagen
Basel, Schweiz CTC Resourcing Solutions VollzeitThe Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Our client, a global market leader in the production and process...
-
RA Manager, Basel
Vor 2 Tagen
Basel, Schweiz TN Switzerland VollzeitProclinical is seeking a Regulatory Affairs Manager to join our client's team in Basel, Switzerland. This role focuses on supporting regulatory submissions for biological medicinal products within the dermatology sector. You will play a crucial role in ensuring compliance and facilitating communication with health authorities.Please note that to be...
-
Senior Project Manager
Vor 6 Tagen
Basel, Schweiz DSJ Global VollzeitSenior Project Manager (m/f/d)Are you ready to take your project management expertise into the dynamic world of Pharmaceutical & BioTech? A prestigious organisation in Basel, Switzerland is seeking a seasoned Senior Project Manager with experience in EPCM plant construction projects. This is an opportunity for permanent employment where you will be at the...
-
QA Manager GMP/GDP
vor 1 Woche
Basel, Schweiz CTC Resourcing Solutions VollzeitQA Manager (GMP/GDP) – 6166 ADAOur client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a QA Manager with GMP and/or GDP experience for 1 year contract with high possibility of extension based in...
-
QA Manager GMP/GDP, Basel
Vor 2 Tagen
Basel, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Responsibilities:Provide GMP/GDP quality assurance expertise during development and commercialization of client’s products.Ensure all required quality activities are initiated and completed according to the development stage.Ensure that medicinal products are designed, developed, manufactured and controlled...
-
Manager, Regulatory Strategy
Vor 6 Tagen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...
-
Senior Project Manager EPCM Projects
Vor 5 Tagen
Basel, Schweiz DSJ Global VollzeitSenior Project Manager - (m/f/d)Are you ready to take your project management expertise into the dynamic world of Pharmaceutical & BioTech? A prestigious organisation in Basel, Switzerland is seeking a seasoned Senior Project Manager with experience in EPCM plant construction projects. This is an opportunity for permanent employment where you will be at the...