Regulatory affairs specialist Jobs in Basel
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Regulatory affairs specialist • basel
Zuletzt aktualisiert: vor 4 Stunden
As a member of the EU Product Registration Team within Europe Crop Protection Regulatory Operations, you will : .Support the management of crop protection product registration dossiers under EU Regul...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Regulatory Affairs Professional (m / w / d).Navigate Complex Regulatory Landscapes – Join Our Expert Network.Building our Regulatory Affairs network .
Switzerland (Basel, Zurich, Bern region)...Mehr anzeigenZuletzt aktualisiert: vor 28 Tagen
Innovative Produkte hautnah - Region Basel.Unser Kunde ist ein pharmazeutisches Familienunternehmen in der Health Care Branche im Grossraum Basel.
Der Hauptsitz und Standort in der Schweiz forscht, ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
- Gesponsert
Manager Regulatory Affairs And Cmc
CARBOGEN AMCISBubendorf, CH Reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, BLAs and MAAs) in accordance with the requirements of the authorities and customers r...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Quality Manager, Regulatory Affairs
PKS Personal AGBinningen, Baselland, CH Chemie, Life Sciences, Biotechnologie.Englisch (fliessend in Wort und Schrift).Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Project Manager
Thermo Fisher ScientificBasel, Basel-Stadt, Switzerland Candidates able to onboard fast and support projects immediately (IND EOP BLA post-marketing variations.They need to be very experienced in building project plans using MS Project and OnePager Pro ...Mehr anzeigenZuletzt aktualisiert: vor 5 Tagen
Regulatory Managing Scientist
ExponentBasel, CH We are currently seeking a Regulatory Managing Scientist to support project teams working on regulatory submissions for the registration of plant protection product in Europe.The role could be base...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Director, Global Regulatory Operations
Ultragenyx PharmaceuticalBasel, Basel-Stadt, Switzerland 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 achie...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
Senior Global Labeling Manager
CTCBasel and NW Switzerland, CH The Life Science Career Network.CTC specializes in helping companies find top talent, providing HR, consulting services, and skill development programs.
We help candidates advance their careers with...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs CMC Manager (Cell & Gene Therapies)
NovartisBasel, Basel-Stadt, Switzerland LI-Hybrid (3 days per week on-site).As a manager in our team youll provide strategic and operational direction for CMC regulatory activities across the product lifecyclefrom development through pos...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
Head of Regulatory Affairs, Europe
BeiGeneBasel BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Operations Specialist - Crop Protection
Eurofins Switzerland PSSBasel, Basel-Stadt, SwitzerlandHomeoffice
- Gesponsert
Pharmaceutical Artwork Specialist
Eumedica Pharmaceuticals AGBasel, CH EUMEDICA Pharmaceuticals AG is an independent and privately owned pharmaceutical company founded inin the heart of Basel, Switzerland.
Our responsibility is to ensure continuity of access to patient...Mehr anzeigenZuletzt aktualisiert: vor 8 Tagen
Pharmaceutical Operations Manager
Cpl Life SciencesSwitzerland, Basel City, Europe As Pharmaceutical Operations Manager in the Manufacturing Science and Technology department (MSAT), you will contribute to the MSAT team at the Basel site and report to the Head of MSAT.In this rol...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Operations Specialist - Crop Protection
EurofinsBasel, BS, CH As a member of the EU Product Registration Team within Europe Crop Protection Regulatory Operations, you will : .Support the management of crop protection product registration dossiers under EU Regul...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
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Associate Director, Global Labeling Product Leader (1 of 2)
Johnson and JohnsonAllschwil, CH At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments a...Mehr anzeigenZuletzt aktualisiert: vor 4 Stunden
Regulatory Affairs Professional (m / w / d)
nemensis agSwitzerland, Basel-Stadt, SchweizQuick Apply
Regulatory Affairs Manager (a)
Michael PageBasel-City, CH The RA will be responsible for timely planning, preparation and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.Tasks will i...Mehr anzeigenZuletzt aktualisiert: vor 29 Tagen
Associate Director - Regulatory Affairs Consultant
ProclinicalBasel, Switzerland We are seeking a Regulatory Affairs Consultant, including the preparation and submission of initial Marketing Authorization Applications (MAAs).
Please note that to be considered for this role you m...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Global Medical Lead – Early Clinical Development (Oncology)
LHHBasel-Stadt, Basel-Stadt, Switzerland Global Medical Lead – Early Clinical Development (Oncology).Employment Type : Temporary Project.Experience Level : Senior (7+ years).
We are hiring on behalf of our customer in Basel for a.This strate...Mehr anzeigenZuletzt aktualisiert: vor 10 Tagen
Manager, RA Submissions
Johnson & JohnsonArlesheim, Basel-Landschaft, Switzerland At Johnson & Johnsonwe believe health is everything.Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are ...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
Regulatory Affairs Manager 50%
gloor&lang AGBasel, Basel City, SwitzerlandQuick Apply
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Manager Regulatory Affairs And Cmc
CARBOGEN AMCISBubendorf, CHVor 30+ Tagen
StellenbeschreibungMaster / Engineering or Ph.D degree in Biochemistry / Biology, Pharmacy or equivalent scientific discipline. Good understanding of regulatory affairs for Drug Substance with a focus on CMC development for Biologics - You have expertise in drafting IND / IMPD / MAA / BLA regulatory files from scratch ; experience in CMC regulatory affairs Drug Substance for small molecules is an added value. Good knowledge of cGMP regulations. Good knowledge of ICH guidelines and regulatory requirements for Biologics and Small Molecules. At least 5 years experience in the pharmaceutical industry / GMP environment : several years in a Regulatory Affairs department combined with previous CMC (R&D, Operations, Analytics) function. Previous experience in CDMO or working in customer projects is a clear advantage. Team oriented, pro-active / problem-solving mentality, service-oriented mindset with flexibility to handle multiple tasks, flexible working ‘attitude'. Good coordination and communication skills – Fluency in English required; Basic knowledge German is recommended. Good sense of responsibility and reliability. Knowledge of eCTD submission software (Docubridge) is an advantage.
Your responsibilities :
- Reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, BLAs and MAAs) in accordance with the requirements of the authorities and customers requirements as well as international guidelines.
- Assisting with the submission of post-approval change documentation.
- Regulatory assessment in terms of change management (change controls, deviations).
- CMC regulatory support during the entire process and product development from the pre-clinical via the clinical phases to market launch, internally and in relation to customer projects / attending customer meetings and project team meetings.
- Performing a regulatory review of the source documents in support of the CMC documentation.
- Leading and / or conducting project specific CMC regulatory gap analysis as driver for CMC development (mainly ADCs / Bioconjugates portfolio and derivatives).
- Collaboration with the Health Authorities / customers : preparing briefing documents, answers to questions from authorities on submitted registration documents.
- Regulatory affairs advise and hands-on support internally for improvement and customer oriented regulatory projects.
Your profile :
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