Cmc Dossier Manager

**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...

**Company Description** **_ At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get...

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...

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...

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...

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 Life Science Career Network** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an **Regulatory Affairs CMC Manager** **for 18 month contract role based in Basel, Switzerland.** As Associate Manager within our Global Regulatory Affairs CMC team, you...

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...

**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...

**The Role**: **Here’s What You’ll Do**: - Support 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 -...

For our customer located in Basel/Switzerland we are currently looking for a**:Regulatory Affairs CMC Associate Manager **(M/F/x)** - * pay rate range - given by our client: 51 chf/h* * Hiring Manager Job Description: * - As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory...

**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...

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....

**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...

**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...

**Drug Substance CMC Lead** 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...