Ph3EU Senior Global Regulatory Affairs Project Leader- 6943 /h3 pOur client is headquartered in Switzerland – a biotech‑hub of Europe – is a high‑potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a EU Senior Global Regulatory Affairs Project Leader for a initial 2 years contract based in Basel. /p pThe EU Senior Global Regulatory Affairs (RA) Project Leader provides strategic regulatory leadership for the development, approval, and life‑cycle management of innovative medicinal products across Europe. The role partners closely with global cross‑functional teams and acts as a key interface with the European Medicines Agency (EMA) and EU National Competent Authorities to enable timely, compliant regulatory pathways. /p pMain Responsibilities: /p ul liDefine and execute EU regulatory strategies in alignment with global development plans /li liServe as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities /li liLead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages /li liOversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life‑cycle updates /li liEnsure EU labeling compliance and alignment with the Company Core Data Sheet /li liRepresent Regulatory Affairs on cross‑functional project and governance teams /li liMaintain regulatory intelligence and assess impact of new guidance and regulations /li liContribute regulatory expertise to due diligence and business development activities /li liDevelop and lead global regulatory strategies and Regulatory Functional Plans /li liCoordinate global submission planning and execution /li liOwn creation and maintenance of the global Company Core Data Sheet /li liLead regulatory sub‑teams and ensure delivery of regulatory milestones /li liSupport affiliates and partners with global regulatory strategy and execution /li /ul pQualifications and Experience: /p ul libRelevant Swiss working/residency permit and/or Swiss/EU‑Citizenship required; /b /li liMaster’s degree (or equivalent) in Life Sciences or related discipline /li li8+ years of Regulatory Affairs experience within pharma or biotech /li liExpert knowledge of EU, ICH, and global regulatory frameworks /li liExtensive experience working with EMA and EU National Competent Authorities /li liStrong understanding of clinical development and regulatory life‑cycle activities /li liExcellent communication, stakeholder management, and project leadership skills /li liFluent English (written and spoken) /li /ul /p #J-18808-Ljbffr