adesta - success is our attitude
adesta sees itself as a partner for customers as well as for employees and applicants. Each appreciate the high-quality, individual advice and support which they receive at adesta.
On behalf of our client, a world-renowned pharmaceutical enterprise with headquarters in the Rhine Main area, we are looking for a
Interim Labeling Manager (m/f/d) in Rhein-Main-Gebiet
Rhein-Main-Gebiet
Full time
Freie Mitarbeit/Dienstvertrag/Projekt
Your tasks
- Creates and maintain Global Regulatory Product Information (Reference Product Information, RPI) documents as the basis for worldwide harmonized Labeling
- Leads all labeling-related activities within the cross functional product teams (e.g. Regulatory Sub-Team, Labeling Team, Global Project Team) for assigned products
- Ensures consistency between the RPI and national labeling documents and provide labeling related advise to the cross functional experts and to countries
- Coordinates and prepares response to labeling-related questions from authorities (content and format)
- Oversees creation and maintenance of minimum text requirements for global Master Packaging as the basis for worldwide harmonized packaging material
- Analyses competitor labeling
- Be aware of local and regional labeling requirements, particularly EU
- Provides revised SmPC, labelling and PL texts in English for EU procedures ( CP, MRP, DCP)
- Coordinate translations for CPs
- Have a solid knowledge on Pharmacovigilance requirements
- Working place: 80% on site, 20% remote
Your Profile
- Pharmacist, chemist, biologist (f/m/d) or similar background
- At least 5 years regulatory and labeling experience in Pharma Industry
- Solid problem solving skills
- Excellent communication skills
- Fluency in English (oral and written)
Are you interested in this challenging freelance job? Then please submit your profile (in English) under specification of reference number 29-302-244. If you have any questions, please do not hesitate to contact Mr. Jungclaus.
