Senior Manager focusing on managing security compliance services for clients in a top CPA firm. Leading client relations and compliance activities in a collaborative team environment.
TK
Hybrid Regulatory Affairs Manager – Generika
Posted 2 weeks ago
About the role
- Regulatory Affairs Manager handling drug approval processes and regulatory affairs. Working with authorities and ensuring compliance for a leading international pharmaceutical firm in Munich.
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
Occupational Health and Safety Intern at Grifols supporting safety improvement initiatives and project management. Collaborating with OHS team on various projects to enhance site safety culture.
Senior Compliance Officer providing regulatory compliance advice and oversight at Starling Bank. Ensuring business teams effectively manage compliance risks and customer outcomes.
Student Assistant supporting the compliance team in day - to - day operations and regulatory processes at Tangany, a digital asset custody services company.
Analyst ensuring compliance with International Trade regulations at Emerson. Supporting business units in managing trade compliance programs and FTA qualification in Philippines.
Corporate Due Diligence Executive managing client onboarding and compliance processes for fintech company. Conducting reviews, due diligence, and collaboration with legal and operations teams.
Compliance Director safeguarding Zodia Custody against financial crime under Luxembourg regulations. Ensuring a robust compliance framework and managing regulatory requirements.
Compliance Specialist responsible for transport compliance and regulatory obligations at Team Global Express. Focusing on safety and efficiency within delivery partner network and mentoring teams.
Head of Risk & Regulatory Compliance leading risk management and compliance in Meruriyo’s Croatian entity. Ensuring alignment with EU regulatory requirements for crypto - asset services.
Regulatory Compliance Manager overseeing compliance matters for a leading international financial institution. Ensuring alignment with regulatory requirements across corporate and investment banking businesses in an international environment.