Aktuelle Jobs im Zusammenhang mit Regulatory Affairs CMC Manager - Basel - Novartis
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Regulatory Affairs CMC Manager, Drug Substance
Vor 4 Tagen
Basel, Schweiz Trades Workforce Solutions VollzeitRegulatory Affairs CMC Manager (Drug Substance – ADC focus) – Basel, Switzerland 📍 4 days on site / 1 day remote💶 Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions...
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Regulatory Affairs Manager Cmc
Vor 5 Tagen
Basel, Schweiz Coopers Group AG VollzeitRegulatory 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...
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Basel, Schweiz Barrington James VollzeitOverviewJoin to apply for the Regulatory Affairs CMC Manager, Drug Substance, ADC role at Barrington James.Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remoteSalary range: 105K–120K CHFResponsibilitiesLead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and...
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Regulatory Affairs Cmc Manager
Vor 5 Tagen
Basel, Schweiz SimplyVision GmbH VollzeitFor our customer located in Basel/Switzerland we are currently looking for a**: Regulatory Affairs CMC Manager **(M/F/x) **Tasks & Responsibilities / Must Haves** - Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for...
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Basel, Schweiz Trades Workforce Solutions VollzeitA leading workforce solutions provider is seeking a Regulatory Affairs CMC Manager for a role focused on drug substance, particularly antibody-drug conjugates (ADCs). The successful candidate will lead CMC regulatory activities, author submissions, and collaborate with external partners in Basel, Switzerland. A strong background in CMC processes and solid...
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Regulatory Cmc Manager
Vor 5 Tagen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...
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Regulatory Affairs Manager
vor 1 Woche
Basel, Schweiz Proclinical VollzeitProclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now! **Responsibilities**: - Conduct regulatory evaluations for aberrations and change control. -...
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Director of Regulatory Affairs Cmc
vor 2 Wochen
Basel, Schweiz Proclinical VollzeitProclinical 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,...
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Regulatory Affairs CMC Manager, Drug Substance, ADC
vor 2 Wochen
Basel, Schweiz Barrington James Limited VollzeitMust be based/willing to travel to Basel, Switzerland4 days on site / 1 day remote Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 &...
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Regulatory Affairs CMC Manager, Drug Substance, ADC
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Barrington James Vollzeit CHF 105'000 - CHF 120'000 pro Jahr**Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remote**Salary range: 105K–120K CHFResponsibilitiesLead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates.Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 &...
Regulatory Affairs CMC Manager
vor 4 Wochen
Job Description Summary #LI-Hybrid (3 days per week on-site) Location Basel Switzerland As a manager in our team youll provide strategic and operational direction for CMC regulatory activities across the product lifecycle from development through post-approval. Your deep understanding of drug development manufacturing and analytical testing combined with a collaborative and patient-focused mindset will help shape the future of our innovative therapies. Job Description Major accountabilities Formulate and lead global CMC regulatory strategy with a focus on innovation balancing business benefit with regulatory compliance. Lead and implement global CMC submission activities (planning authoring reviewing coordination submission) for assigned projects / products. Identify the required documentation and any content quality and / or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and / or review high-quality CMC documentation for HA submission applying agreed CMC global regulatory strategies current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance meeting agreed upon timelines and e-publishing requirements. Proactively communicate CMC regulatory strategies risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams. Prepare and communicate CMC risk management assessments and lessons learned on major submissions. Initiate and lead Health Authority interactions and negotiations. Minimum requirements Science degree (e.g. Chemistry Pharmacy Biochemistry Molecular Biology Biotechnology Biology) or equivalent At least 2 years experience in regulatory CMC experience and / or pharmaceutical industry experience; working knowledge in regulatory submissions desirable. Demonstrated working knowledge of chemistry / biotechnology analytics or pharmaceutical technology. Knowledge / experience of regulations guidelines and product life cycle maintenance. Ability to critically evaluate data from a broad range of scientific disciplines. Commitment to Diversity and Inclusion / EEO Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired Change Control Cross-Functional Teams Documentation Management Negotiation Skills Regulatory Compliance Risk Assessment Risk Management Waterfall Model Required Experience Manager Key Skills Proofreading Adobe Acrobat FDA Regulations Manufacturing & Controls Biotechnology Clinical Trials Research & Development GLP cGMP Product Development Chemistry Writing Skills Employment Type: Full-Time Experience: years Vacancy: 1 #J-18808-Ljbffr
