Project Support (m/w/d) Pharmaceutical Group | Quality / Regulatory Affairs Department (Regulatory Affairs Manager)

Other job titles: Regulatory Affairs Specialist (Pharma); Project Coordinator Pharma / Project Support Pharma; Regulatory Data Steward / Data Manager Pharma; Quality Systems Specialist (Pharma)

Job Description: On behalf of our client, a world-leading pharmaceutical company, we are looking for you as:

Project Support (m/w/d) Pharmaceutical Group | Quality / Regulatory Affairs Department – Non-tariff classification

Your Tasks

• Training in the creation of system links together with the Regulatory Data Steward and the responsible Regulatory System Owner (RSO)
• Training and application of a specialized linking tool for data maintenance in regulatory systems
• Independent development and implementation of linking proposals in the data maintenance system
• Identification of the need for correction and submission of correction proposals for validation by the RSO in the deployed Regulatory IT systems
• Quality assurance: Second check of the links after correction has been completed
• Monitoring and reporting of the deployment progress at the location
• Regular participation in project-related community meetings with internal stakeholders

Your Profile

Must Haves:

• Good written and spoken English skills
• Knowledge of the regulatory environment (Regulatory Affairs / CMC)
• Experience with Veeva-based systems (e.g., Veeva RIM)

Nice-to-haves

• Experience with GMID or comparable global product identification systems
• Affinity for databases and data maintenance in complex IT system landscapes
• Experience in regulated pharmaceutical environments (GxP)

Our Offer

• Assignment at an internationally leading pharmaceutical company at the Frankfurt location
• Attractive non-tariff remuneration
• Flexible working arrangements with flextime and home office possible by arrangement
• Training in specialized regulatory IT systems and global data processes
• Collaboration with global teams and participation in project-wide community meetings
• Clearly defined project assignment of 6 months with structured onboarding
• Professional induction in a collegial, supportive team
• Personal support by BS during the entire assignment period and perspective for permanent employment

Additional Information: Home office: Extent: By arrangement Requirements for the applicant: Advanced knowledge: Quality inspection, quality assurance, international pharmaceutical standards (e.g., GLP, GMP), proofreading, reporting, information, monitoring Expert knowledge: Regulatory Affairs (marketing authorization), Customer-Relationship-Management software Veeva CRM