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Regulatory Specialist - Commercial / Post-Marketing und Remediation – Basel | JobRevolt

Über den Job

As a first-tier supplier to our renowned business partner F. -La Ltd. in Basel, we are seeking a motivated Regulatory Specialist - Commercial / Post-Marketing & Remediation (CMC) for a temporary assignment of 12 months. The position focuses on post-approval regulatory maintenance, change controls, regulatory deviations, system integration and remediation of legacy regulatory data and records.

Aufgaben

Independently manage and execute global technical regulatory submissions for commercial products, ensuring compliance with local and regional registration requirements, internal policies and audit standards
Manage the regulatory lifecycle of assigned commercial products
Assess technical change records for regulatory impact and coordinate required post-approval regulatory activities
Support post-marketing submissions, change controls and regulatory deviations
Maintain and remediate CMC regulatory documentation and data in Veeva RIM and related document management systems
Support system integration and clean-up of legacy regulatory information
Represent Pharma Technical Regulatory on cross-functional project teams and provide regulatory advice
Collaborate with local and global technical teams to ensure continued regulatory compliance
Support interactions with Health Authorities and external partners on assigned technical topics
Identify regulatory risks and proactively improve tracking, control systems and workflows
Monitor changes in global regulatory requirements and assess potential impacts on marketed products and lifecycle strategies

Profil

Minimum Bachelor's degree in a relevant field
3-4 years of CMC regulatory / technical regulatory experience
Experience supporting commercialized pharmaceutical products
Experience with post-approval / post-marketing regulatory maintenance
Experience with regulatory change controls
Experience managing or supporting regulatory deviations
Working knowledge of legacy / old product data clean-up and remediation
Strong proficiency in the Veeva RIM environment
Experience maintaining regulatory submission documentation in Veeva
Fluent English, written and spoken, minimum C1
Proactive problem-solving ability and willingness to streamline legacy records and processes

Rahmenbedingungen

Arbeitsort: Basel
Pensum: 100%
Befristung: 12 Monate
Position: Mitarbeiter
Branche: Pharma + Chemie + Life Science
Bewerbung: Reichen Sie Ihre vollständigen Bewerbungsunterlagen online ein

Benefits

Work with modern and up-to-date tools in an innovative work environment
Experience a work culture that promotes diversity and inclusion and where all employees feel valued
Benefit from financial support for your professional development plans
Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card
Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
Take advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat
Enjoy a selection of high-quality meals in modern staff restaurants
As part of a sustainable mobility concept, on-site parking spaces are available, provided you meet the relevant qualifications
Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days

Regulatory Specialist - Commercial / Post-Marketing und Remediation

Über den Job

Über den Job

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