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Regulatory affairs specialist Jobs in Basel

Zuletzt aktualisiert: vor 1 Tag
Regulatory Affairs Manager

Regulatory Affairs Manager

CTCBasel and NW Switzerland, CH
Mehr anzeigenZuletzt aktualisiert: vor 9 Tagen
Quality Manager, Regulatory Affairs

Quality Manager, Regulatory Affairs

PKS Personal AGBinningen, Baselland, CH
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Director Regulatory Affairs Biosimilars

Associate Director Regulatory Affairs Biosimilars

AbbottBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor 15 Tagen
Pharmaceutical Market Researcher

Pharmaceutical Market Researcher

Hire DigitalBasel, CH
Quick Apply
Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
ENRICHMENT - Guest Lecturer - World Affairs

ENRICHMENT - Guest Lecturer - World Affairs

VikingBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Clinical Trial Regulatory Lead

Clinical Trial Regulatory Lead

RocheCity, Switzerland
Vollzeit
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Manager, Regulatory Affairs

Manager, Regulatory Affairs

LonzaBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Senior Manager Corporate Regulatory Affairs & Cmc

Senior Manager Corporate Regulatory Affairs & Cmc

CARBOGEN AMCISBubendorf, CH
Mehr anzeigenZuletzt aktualisiert: vor 20 Tagen
Head of International Regulatory Affairs - Apraglutide

Head of International Regulatory Affairs - Apraglutide

Ironwood PharmaceuticalsBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
REACH Regulatory Project Manager

REACH Regulatory Project Manager

ExponentBasel, CH
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Global Medical Affairs Scientist / Manager

Global Medical Affairs Scientist / Manager

BasileaAllschwil, CH
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Manager – CMC Dossier Manager (M / F)

Senior Manager – CMC Dossier Manager (M / F)

Aixial GroupBasel city
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Drug Regulatory Affairs Manager 80-100%

Drug Regulatory Affairs Manager 80-100%

Gi Group SABasel, Basel-Stadt, Schweiz
Quick Apply
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Global Regulatory Affairs Associate, Fast Growing Dermatology Company

Global Regulatory Affairs Associate, Fast Growing Dermatology Company

Stratpharma AGBasel, Basel City, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Companion Diagnostics Lead m / f / d

Companion Diagnostics Lead m / f / d

BayerBasel, Basel-City, CH
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager Schweiz

Regulatory Affairs Manager Schweiz

gloor&lang AGBasel, Basel City, Switzerland
Quick Apply
Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Senior manager - global regulatory affairs (m / w / d) 100%

Senior manager - global regulatory affairs (m / w / d) 100%

nemensisSwitzerland, Basel-Landschaft, Basel-Land
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regulatory Affairs Manager (m / w / d)

Regulatory Affairs Manager (m / w / d)

HaysBasel Stadt
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Associate Medical Affairs / Medical Information (m / w / d) 50-70%

Associate Medical Affairs / Medical Information (m / w / d) 50-70%

Teva PharmaceuticalsBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor 14 Tagen
Team Leader Regulatory Affairs & Compliance - Regenerative Solutions (m / f / d)

Team Leader Regulatory Affairs & Compliance - Regenerative Solutions (m / f / d)

Straumann GroupBasel, Switzerland
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager

Regulatory Affairs Manager

CTCBasel and NW Switzerland, CH
Vor 9 Tagen
Stellenbeschreibung

Main Responsibilities :

  • Author and review CTD module 3.2 sections (drug substance / drug product) for biologicals medicinal products;
  • Prepare high-quality clinical trials applications, BLA / MAA, and post-approval submissions;
  • Manage timely responses to Health Authority (HA) questions;
  • Lead and coordinate activities to ensure submission deadlines are met;
  • Communicate and escalate risks and issues to management and project teams, as applicable;
  • Act as RA Point of Contact or RA team member for assigned projects;
  • Manage change Controls and Deviations;
  • Support site-specific regulatory documentation and activities.

Qualifications and Experience :

  • Relevant working / residency permit or Swiss / EU-Citizenship required;
  • A Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy or equivalent;
  • At least 5 years in authoring high-quality CMC CTD sections (content and format) for drug substance, drug product, and appendices from first-in-human to post-approval for biological medicinal products;
  • Good understanding of manufacturing processes and quality control for biological medicinal products;
  • Strong knowledge of CMC requirements for biologics as well as good procedural knowledge (EU and US; other markets is a plus);
  • Good CMC writing skills;
  • Previous experience in contractor environment e.g. CMO / CDMO, CRO, Consultancy is an advantage.