Regulatory Specialist - Clinical / Early-Stage Development (CMC) (m/f/d)

pAs a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel, we are currently looking for a motivated and dedicated bRegulatory Specialist – Clinical / Early-Stage Development (CMC) /b for a temporary assignment of 12 months. /p pA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. /p pThat’s what makes us Roche. /p pAt Roche, we believe in empowering you to thrive and do your best work. By bringing together our unique strengths in technical regulatory affairs, medicines, and technology, you will collaborate in an environment that nurtures growth, values your unique perspective, and drives sustainable innovation to transform healthcare for patients worldwide. /p pIn the position of Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR), you will be accountable for handling Health Authority interactions pertaining to CMC information, including IND, IMPD and related clinical regulatory submissions. /p pThis position is specifically focused on early clinical development, supporting Investigational Medicinal Products (IMPs), Investigational Medicinal Product Dossiers (IMPDs) and Clinical Trial Applications (CTAs). /p pThe role requires strong technical CMC regulatory expertise, close collaboration with global stakeholders and proficiency in Veeva Document Management to support compliant regulatory submissions. /p h3Tasks und Responsibilities /h3 ul liIndependently manage and execute global technical regulatory submissions for clinical products, ensuring compliance with local and regional registration requirements, internal policies and audit standards. /li liSupport CMC regulatory activities for early clinical development programs. /li liPrepare and coordinate IMPDs and other technical documentation required for Clinical Trial Applications. /li liSupport regulatory strategies aimed at enabling timely approval of CTAs. /li liEvaluate technical information and changes for potential regulatory impact. /li liMaintain CMC documentation within Veeva Document Management. /li liRepresent Pharma Technical Regulatory on cross-functional project teams and provide regulatory advice. /li liCollaborate with global technical teams, affiliates and other stakeholders. /li liSupport interactions with Health Authorities and external partners on assigned technical topics. /li liIdentify regulatory risks and support improvements to submission processes and workflows. /li liMonitor relevant changes in global regulatory requirements and assess their potential impact on development programs. /li /ul h3Must Haves /h3 ul liMinimum Bachelor’s degree in a relevant field /li li3–4 years of CMC regulatory / technical regulatory experience /li liExperience in CMC regulatory support for early clinical trials /li liExperience with Investigational Medicinal Products (IMPs) /li liHands-on experience preparing or supporting Investigational Medicinal Product Dossiers (IMPDs) /li liExperience with Clinical Trial Applications for early- to mid-stage development programs /li liSolid hands-on experience with Veeva Document Management for regulatory submissions /li liFluent English, written and spoken, minimum C1 /li /ul h3Nice to Haves /h3 ul liGerman language skills /li liPrevious Roche experience /li liExperience with biologics /li /ul h3Benefits /h3 ul liWork with modern and up-to-date tools in an innovative work environment /li liExperience a work culture that promotes diversity and inclusion and where all employees feel valued /li liBenefit from financial support for your professional development plans /li liTake advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands /li liBenefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card /li liBecome part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare /li liWork on a state-of-the‑art campus featuring green spaces, meeting areas, and an inspiring atmosphere /li liTake advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat /li liEnjoy a selection of high-quality meals in modern staff restaurants /li liAs part of a sustainable mobility concept, on‑site parking spaces are available to you, provided you meet the relevant qualifications /li liStart with a professional onboarding process and a thorough introduction to your new role during the Welcome Days /li /ul pWir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen – unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint. /p #J-18808-Ljbffr