Head of Cmc/cmc-qa

GRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO’s differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic...

GRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO’s differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic...

GRANITE BIO is a recently established biotechnology company in the Ridgeline Discovery incubator located in Basel (Switzerland). Based on fundamental research over the last two decades, GRANITE BIO’s differentiated approach is to impact central disease biology nodes to transform inflammatory, autoimmune and fibrotic conditions. The lead therapeutic...

The Role As Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely...

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Head of CMC Program...

**CMC Regulatory Project Coordinator** You will be repsonsible for coordinating the budget of the CMC development activities of the late stage phase within the CMC Development organization. You will collaboaret with internal and external partners to support deliverables according to project timelines and defined budget. **Responsibilities**: - Monitoring...

Hobson Prior are looking for a RA CMC Manager to join a brilliant pharmaceutical corporation on a contract basis located in Basel. Our client is focused on improving and prolonging the lives of many. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this position, you will be...

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **CMC Lead Drug...

Abbott Established Pharmaceuticals EPD is looking for a **Director Regulatory Affairs CMC & Operations***:To be based in our Divisional Headquarter in Basel-Allschwil, Switzerland **Primary Job Function**: - Provide strategic global regulatory guidance and leadership on CMC related matters for pipeline development products and on-market products for a...

576! 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 pa-tients’ lives and we need your help. As a member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and...

**The Role**: **Here’s What You’ll Do**: Lead a team to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide expertise for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health...

**The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

**The Role**: **Here's What You’ll Do**: Provide leadership for regulatory CMC aspects of product development projects Lead and drive all CMC submission activities (planning, Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Develop effective CMC regulatory strategies for submissions (e.g....

583! 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 member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational...

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, there is more we can do to help improve and extend people’s lives - In Global Regulatory Affairs CMC, our work starts when a compound goes into clinical trials. Novartis has a unique and promising portfolio. All of these innovative projects are aimed at making a...

Regulatory Affairs Manager CMC For our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects. **Responsibilities**: - Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical...

**The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

Duration: 30/10/2025, possible extensionKey Responsibilities:Manage timely responses to Health Authority (HA) questions (author/ review)Draft/ review briefing documents to support e.g. scientific advice procedures/ meetings with HALead/ coordinate/ communicate/ track activities to ensure submission deadlines are met in accordance with procedures: e.g....

**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...

Regulatory Affairs Manager/CMC Duration: 30/10/2025, possible extension **Key Responsibilities**: - Manage timely responses to Health Authority (HA) questions (author/ review) - Draft/ review briefing documents to support e.g. scientific advice procedures/ meetings with HA - Lead/ coordinate/ communicate/ track/ activities to ensure submission deadlines...