Associate Director Cmc of Technical Development

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 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...

**Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development Luzsana Biotechnology (Luzsana), is a global, purpose-driven innovative medicines company committed to delivering medicines that...

**Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development Luzsana Biotechnology (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines...

**The Role**: Reporting to the Director, Product Quality Lead the Associate Director, Product Quality Lead will be responsible for developing, approving, monitoring and maintaining critical quality standards, identifying quality risks, ensuring quality management of product and processes lifecycle, leading improvement and alignment with current regulatory...

**The Role**: **Here’s What You’ll Do**: - Develop/implement effective CMC regulatory strategies for global 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...

**The Role**: **Here’s What You’ll Do**: Develop/implement effective CMC regulatory strategies for global 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...

Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel. **Responsibilities**: - Lead the system owners through the issuance, proposal and upkeep of all regulatory documents such as DMF's, CMC documentations for INDs, IMPDs, NDAs, MAAs,...

CMC Technical Dossier Manager Role & Function The CMC Dossier Manager is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and...

**Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development **About Hengrui**: The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative...

Arxada is a global specialty chemicals business that’s committed to solving the world’s toughest preservation challenges through better science. [With a proud history of innovation dating back more than a century], we aim to help our customers develop more sustainable solutions that protect and maintain the health and wellbeing of people and extend the...

(Senior) Technical Regulatory Program Director New ModalitiesThe PositionAre you eager to join a team dedicated to bringing new medicines to patients? Roche is seeking a (Senior) Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department.At Roche, Technical Regulatory plays a crucial role in developing new medicines and...

**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...

Are you passionate about building strong client relationships and identifying business opportunities? Do you thrive in dynamic environments and enjoy working closely with clients to deliver customized solutions? TFS HealthSciences, a leading Contract Research Organization (CRO), invites you to join as an Associate Director of Business Development for...

As Technical Associate Director User Research (UX), you will be a member of the Business Engagement team in the Novartis Institutes for BioMedical Research (NIBR) Informatics team in Switzerland. Our team helps to analyse and triage incoming demand from our scientific stakeholders, so that our product organization can focus on delivering products and...

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

OverviewNovartis Farmacéutica seeks a seasoned professional to lead its Scientific Office for Drug Product Development Biologics. As the Director of this team, you will be responsible for advancing biologics product development and delivery technologies.About the RoleLead the Scientific Office in drug product development, ensuring scientific rigor and...

Associate Director, Biologics Manufacturing Management Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this...

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

Switzerland, Basel- 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 together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas,...

10 major new medicines planned for launch over the next few years creating new career opportunities for those who want to make a direct impact on patients at scale improving people’s lives. Novartis Oncology has a renowned history in hematology and oncology of developing transformative therapies for patients. - As the Associate Clinical Development Medical...