regulatory submissions

Johnson Johnson is seeking a Submissions Reg Intelligence Manager within Integrated Data Analytics Reporting (IDAR) to advance the Clinical Data Standards organization and ensure regulatory submission readiness. The role acts as a SME and leader across data standards, collaborating with study teams and regulatory affairs.The position emphasizes coaching,...

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.Reporting to the CMC...

pSkilled – Recruitment Solutions GmbH is seeking a Senior Documentation Quality Specialist to ensure rigor across clinical, nonclinical, and regulatory documents within global development programs. The role emphasizes clarity, regulatory compliance, and governance of templates and standards. /ppThe ideal candidate has a Master’s degree in life sciences...

pCSL is seeking a Senior Manager, Regulatory Submission to join its Global Regulatory Submission Management Team. Based in a hybrid setup spanning key markets, you will drive timely, high-quality regulatory submissions across global markets and coordinate with Regulatory, PM, Publishing and external partners to ensure compliance and risk management. /ppYou...

Monte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls.You will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority...

pCSL is seeking a Regional Regulatory Lead to drive regional regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Based in Zurich or Maidenhead, the role partners with the Global Regulatory Lead to align regulatory plans with commercial priorities. /ppYou will manage submissions, lifecycle activities, Health Authority...

pJohnson Johnson Innovative Medicine is seeking a Submissions Regulatory Intelligence Manager to lead clinical data standards initiatives within IDAR, collaborating with data management, statistics, regulatory affairs and study teams to ensure compliant, timely submissions. /ppThe role spans guidance interpretation, SDTM/ADaM work, and cross-border...

CSL is seeking a Regional Regulatory Lead to drive regional regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Based in Zurich or Maidenhead, the role partners with the Global Regulatory Lead to align regulatory plans with commercial priorities.You will manage submissions, lifecycle activities, Health Authority interactions,...

pTakeda Pharmaceutical Co. in Zurich, Switzerland, seeks a Senior EU Regulatory Lead GII, Director, to define regional regulatory strategies and lead submissions for development and lifecycle management. /ppThe role requires extensive regulatory experience and strong leadership across cross-functional teams. The successful candidate will coordinate with...

h3Senior Manager, Regulatory Submission /h3 pbLocations: /b King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UKbr/bWork Arrangement: /bHybrid - 3 days onsitebr/bReports to: /b Global Submission Management Lead /p pCSL's RD organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong...

pJohnson Johnson Innovative Medicine in Basel-Allschwil, Switzerland, seeks a Submissions Regulatory Intelligence Manager to lead Clinical Data Standards within IDAR, ensuring SDTM/ADaM compliance and regulatory submission readiness across programs. /ppThe role requires a science degree, 6+ years in pharma, and excellent English, with international...

pGi Life Sciences cerca un/una Regulatory Affairs Specialist onsite per contratto temporaneo tramite Gi Group, presso una multinazionale biotech/pharma focalizzata su prodotti medicinali specialistici. /ppLa risorsa si occuperà di preparazione, gestione e caricamento delle submission regolatorie in formato eCTD, gestione documentale, e interazione con team...

pBavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities for biologic products from multiple hubs, enabling registrations and lifecycle management. Located in Martinsried (Munich), Törishaus (Bern) or Kvistgård, you will coordinate submissions across regions and liaise with health authorities worldwide. /ppThe ideal...

Gi Life Sciences cerca un/una Regulatory Affairs Specialist onsite per contratto temporaneo tramite Gi Group, presso una multinazionale biotech/pharma focalizzata su prodotti medicinali specialistici.La risorsa si occuperà di preparazione, gestione e caricamento delle submission regolatorie in formato eCTD, gestione documentale, e interazione con team QA,...

Skilled – Recruitment Solutions GmbH is seeking an accomplished Regulatory Affairs leader to guide European regulatory strategy for a pharmaceutical/biotech portfolio. The role interfaces with EMA and national authorities, designs pathways, and leads submissions throughout lifecycle.You will mentor cross-functional teams, shape clinical development plans,...

Hibob Inc. is seeking a Clinical and Regulatory Affairs Intern to collaborate with our team and an external partner to support clinical and regulatory activities.You will help prepare study documents, ensure regulatory compliance with ISO 14155, and assist with data collection and reporting within our startup framework. You will work closely with clinical...

pMerck Group in Zug, Switzerland, is seeking a Regulatory Affairs Manager on a fixed-term contract (1.1.2027– ) to cover maternity leave. You will drive submission strategies for marketing authorizations and life-cycle management for medicinal products, ensuring timely, compliant regulatory work. /ppYou will collaborate with the Head Regulatory Affairs and...

OM Pharma invites applications for a paid Regulatory Affairs Operations Trainee position based in Meyrin, Geneva, CH. The internship supports regulatory data management, dossier maintenance and electronic submissions, under supervision of the RA Team Lead.You will gain hands-on experience in international regulatory operations, learn about health authority...

Position Summary:The EU CTR Submission Lead is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted under the EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role provides strategic submission planning, cross-functional coordination, and...

At Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...