Regulatory Specialist - Commercial / Post-Marketing + Remediation (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 – Commercial / Post-Marketing und Remediation (CMC) /b for a temporary assignment of 12 months. /ppA 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. /ppThat’s what makes us Roche. /ppAt 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. /ppIn the position of Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR), you will support technical regulatory activities across the lifecycle of commercialized pharmaceutical products. /ppThis position is specifically focused on post-approval regulatory maintenance, change controls, regulatory deviations, system integration and remediation of legacy regulatory data and records. /ppThe role requires strong CMC regulatory expertise, experience working with marketed products and strong proficiency in the Veeva RIM environment. /ph3Tasks und Responsibilities /h3ulliIndependently manage and execute global technical regulatory submissions for commercial products, ensuring compliance with local and regional registration requirements, internal policies and audit standards /liliManage the regulatory lifecycle of assigned commercial products /liliAssess technical change records for regulatory impact and coordinate required post-approval regulatory activities /liliSupport post-marketing submissions, change controls and regulatory deviations /liliMaintain and remediate CMC regulatory documentation and data in Veeva RIM and related document management systems /liliSupport system integration and clean-up of legacy regulatory information /liliRepresent Pharma Technical Regulatory on cross-functional project teams and provide regulatory advice /liliCollaborate with local and global technical teams to ensure continued regulatory compliance /liliSupport interactions with Health Authorities and external partners on assigned technical topics /liliIdentify regulatory risks and proactively improve tracking, control systems and workflows /liliMonitor changes in global regulatory requirements and assess potential impacts on marketed products and lifecycle strategies /li /ulh3Must Haves /h3ulliMinimum Bachelor’s degree in a relevant field /lili3–4 years of CMC regulatory / technical regulatory experience /liliExperience supporting commercialized pharmaceutical products /liliExperience with post-approval / post-marketing regulatory maintenance /liliExperience with regulatory change controls /liliExperience managing or supporting regulatory deviations /liliWorking knowledge of legacy / old product data clean-up and remediation /liliStrong proficiency in the Veeva RIM environment /liliExperience maintaining regulatory submission documentation in Veeva /liliFluent English, written and spoken, minimum C1 /liliProactive problem-solving ability and willingness to streamline legacy records and processes /li /ulh3Nice to Haves /h3ulliGerman language skills. /liliPrevious Roche experience. /liliExperience with biologics. /li /ulh3Benefits /h3ulliWork with modern and up-to-date tools in an innovative work environment /liliExperience a work culture that promotes diversity and inclusion and where all employees feel valued /liliBenefit from financial support for your professional development plans /liliTake advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands /liliBenefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card /liliBecome part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare /liliWork on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere /liliTake advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat /liliEnjoy a selection of high-quality meals in modern staff restaurants /liliAs part of a sustainable mobility concept, on-site parking spaces are available to you, provided you meet the relevant qualifications /liliStart with a professional onboarding process and a thorough introduction to your new role during the Welcome Days /li /ulpWir 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