Senior Manager Regulatory Affairs (gn)

Ihr Aufgabengebiet

• Create and examine documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to Modules 2.4 2.7, responses to the Health Authority questions, clinical study protocols and reports, investigator s brochures, etc.
• Cooperate with different teams, external consultants and suppliers in the implementation of clinical regulatory activities
• Proactive identification of regulatory risks / options and mitigation strategies
• Evaluating regulations,guidelines, procedures etc, providing everything to stakeholders
• Fulfill regulatory submissions by assembling, drafting, editing and reviewing
• Development, including implementation of global regulatory strategies for products
• Close colloboration with with the Health Authorities, preparation and reviewing of briefing documents, inter alia Orphan Designations Applications and Paediatric Investigation Plans

Ihr Hintergrund

• Degree in Life Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
• Experience in regulatory and drug / biologic development, ideally in oncology indication
• Be familiar with preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities.
• Practical Knowledge in preparing and submitting New Drug Applications and Marketing Authorisation Applications through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures
• Expertise in product labels (CCDS, US PI, EU SmPC etc.), writing of regulatory documents, as well as briefing packages for scientific advice meetings, PIP/PSPs etc.
• Good analysis and interpretation skills with clinical data, good interpersonal skills
• Fluent in English, both written and spoken

Ihre Benefits

• Spannende Herausforderungen in einem zukunftstr chtigen und wachsenden Unternehmen
• Eine offene Arbeitsatmosph re in einer offenen Unternehmenskultur mit kurzen Kommunikationswegen
• Ein attraktives Verg tungspaket sowie interessante Weiterentwicklungsm glichkeiten

Gender-Hinweis

Aus Gr nden der besseren Lesbarkeit wird auf die gleichzeitige Verwendung der Sprachformen m nnlich, weiblich und divers (m/w/d) verzichtet. S mtliche Personenbezeichnungen gelten gleicherma en f r alle Geschlechter.