Compliance Intern offering forensic analysis support for Johnson & Johnson. Engaging in audits and analytical tasks in a hybrid work environment in New Brunswick, NJ.
TK
Hybrid Regulatory Affairs Manager – Generika
Posted 5 months ago
About the role
- Regulatory Affairs Manager overseeing drug approval processes at an international Pharma company. Involves documentation, direct contact with authorities, and lifecycle management for products.
Responsibilities
- Eigenverantwortliche Betreuung der Verfahren in der Arzneimittelzulassung
- Die Zulassungsdokumentation im eCTD-Format und deren Einreichung bei den Behörden
- Life-Cycle-Management (Renewals, Variations)
- Direkter Kontakt mit Zulassungsbehörden sowie Ansprechpartner für interne und externe RA Fragestellungen
- Betreuung und Optimierung der regulatorischen Informations-Datenbank
- Erstellen und Prüfen von Produktinformationstexten
Requirements
- Ein abgeschlossenes Studium (z.B. pharmazeutisch/naturwissenschaftlich)
- Berufserfahrung im Bereich Regulatory Affairs
- Sehr gute Sprachkenntnisse in Deutsch sowie Englisch
- Analytisches Denken, schnelle Auffassungsgabe und gute Organisationsfähigkeit
- Teamgeist und Kommunikationsstärke
Benefits
- Flexible Arbeitsbedingungen (inkl. Homeoffice)
- 30 Tage Urlaub + 3 Brückentage
- Ein sympathischen Team
- Attraktives Gehalt & umfangreiche Sozialleistungen (u.a. Alters- und Gesundheitsvorsorge…)
- Hervorragende Weiterbildungsangebote
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Director, Global Regulatory Leader responsible for global regulatory strategies in innovative medicine for investigational products. Leading cross - functional teams and ensuring regulatory compliance with health authorities.
GRC Analyst supporting Siteimprove's security governance, risk, and compliance team. Engaging with customers, managing vendor security reviews, and enhancing security practices.
Compliance Manager overseeing United Rotorcraft’s compliance initiatives with federal standards. Ensuring audit readiness and managing supplier compliance and training programs.
Regulatory Compliance Projects Manager at Betclic ensuring compliance in product development and coordinating regulatory matters across jurisdictions. Leading cross - functional projects in a dynamic environment.
Trade Compliance Officer managing US trade compliance operations for Thales' InFlight Entertainment Business Line. Developing and implementing comprehensive trade compliance programs aligned with regulatory requirements.
Quality & Compliance System Senior Specialist overseeing Quality Management Systems in a global biopharmaceutical company. Ensuring GMP compliance and continuous improvement in quality processes.
Covenant Compliance Review Analyst responsible for monitoring covenant compliance tests and financial statements. Supporting Relationship Managers with compliance and documentation for commercial clients.
Supports the Covenant Compliance Review Department for commercial credit relationships at Origin Bank. Involves financial documentation maintenance and client relationships management.
Quality and Compliance Specialist ensuring compliance with dietary supplement regulations and quality management. Supporting quality programs and regulatory affairs under the Director of R&D and Regulatory Affairs.