Beschreibung
Aktuell bin ich für einen unserer Kunden auf der Suche nach einem Interim CMC / Regulatory Affairs Manager.Aufgaben (u.a.):
- Update existing Module 3 and Module 2 documents (CMC) to fullfill country specific requirements in emerging markets (This includes ASMF documentation) for international registrations with particular attention to ensuring they are prepared with adequate criteria and quality in their technical and regulatory aspects
- Participate in Project Teams and other work groups with the objective of contributing the required CMC regulatory input into pharmaceutical products and devices, as well as drug-device combination products
- Compile Investigational New Drug Application, and IMPD for clinical trials for in-house development products (quality part) - Define strategy and manage and coordinate the resolution of Questions from Health Authorities
Voraussetzungen:
- profund knowledge Regulatory Affairs / CMC - Ability to work in and to lead cross-functional teams
- Ability to work independent
- Good written and spoken communication skills
- English, business fluent
- Experience with medical devices or drug device combination products in emerging markets, e.g. Brasil, China, Turkay, Russia, Japan, South Africa)
Rahmenbedingungen:
Start: ASAP Laufzeit: 8 Monate (Ende 2015)
Volumen: 100% (5 Tage / Woche)
Ort: on-site (Hessen) (3 Tage) + homebased (2 Tage)
Wenn Sie Interesse an dieser Position haben, nehmen Sie bitte gerne Kontakt mit mir per Email auf. Ich melde mich sobald wie möglich zurück.
Für mehr Informationen über Progressive Recruitment, besuchen Sie www.progressiverecruitment.com