regulatory submissions Jobs in Basel

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...

pJohnson 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. /ppThe position emphasizes...

pFlexsis in Basel, Switzerland is seeking a Regulatory Specialist (m/f/d) focusing on CMC regulatory activities for clinical and early-stage development. The role is full-time in Basel with a 12-month contract, likely extendable, and an earliest start date soon with 1 February 2027 latest. /ppYou will support global regulatory submissions for investigational...

pActalent is seeking a Regulatory Specialist (CMC) to drive global regulatory submissions for clinical-stage products and to support IMPDs, CTAs and related CMC documentation. You will liaise with cross-functional teams across development, manufacturing and quality to ensure alignment with Health Authority expectations. /ppThe role requires 3–4+ years in...

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...

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

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,...

Roche Basel seeks a Regulatory Specialist (CMC) focused on Clinical/Early-Stage Development to lead global technical regulatory submissions (IND/IMPD/CTAs) and manage change controls in Veeva environments. The role requires collaboration with PTR, affiliates, and external partners across the product lifecycle.The ideal candidate has a Bachelor in a relevant...

Roche Basel seeks a Regulatory Specialist (CMC) focused on Clinical/Early-Stage Development to lead global technical regulatory submissions (IND/IMPD/CTAs) and manage change controls in Veeva environments. The role requires collaboration with PTR, affiliates, and external partners across the product lifecycle. The ideal candidate has a Bachelor in a relevant...

h3Regulatory Specialist (m/f/d) – Clinical / Early-Stage Development (CMC) /h3 pFor our client, an internationally renowned company in the pharmaceutical and healthcare industry, we are looking for a Regulatory Specialist (m/f/d) with a focus on CMC regulatory activities in clinical and early-stage development. This is a full-time position based in Basel,...

Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of...

pOur client is a global leader in the pharmaceutical industry, committed to advancing science and delivering innovative therapies to patients worldwide. To support ongoing clinical development activities, we are looking for a Regulatory Specialist (CMC) with experience in early-stage development and clinical regulatory submissions. /p /brpIn this role, you...

Johnson & Johnson is seeking a Principal Project Manager to develop and maintain schedules for MDR submissions and act as the primary liaison with EU Notified Bodies for DePuy Synthes. You will lead project planning and execution to support franchise goals across Orthopedics.The role emphasizes cross-functional leadership, regulatory coordination, and...

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.The candidate...

pRevolution Medicines is seeking an experienced Principal Regulatory Medical Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate with Regulatory Affairs, Clinical Development, and cross-functional teams to author, coordinate and finalize submissions. /ppThe role...

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target...

Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of...

Revolution Medicines, Inc. is seeking a Director, Regulatory Affairs, Switzerland, to lead regulatory activities and strategy for Swiss projects in alignment with Swissmedic and ICH guidelines.You will collaborate with medical, clinical, marketing and global RA teams to support lifecycle management, submissions, and compliance across regions. The role...

Arxada is seeking a Regulatory Affairs Manager to lead regulatory activities for Microbial Control Solutions (MCS) paints & coatings across the EMEA region. You will shape regulatory strategies, coordinate submissions and ensure compliance while collaborating with commercial, R&D and regulatory colleagues.Location options include Manchester (UK), Barcelona...

pRevolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly...