Interim Labeling Manager (m/f/d)

adesta GmbH & Co. KG; Osterwieck; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A prestigious pharmaceutical enterprise is seeking an Interim Labeling Manager to oversee labeling-related activities and ensure regulatory compliance. Candidates should have significant experience in the Pharma industry, with strong problem-solving and communication skills, as well as fluency in English. The position allows for a hybrid working environment, offering flexibility.

Qualifikationen

• At least 5 years regulatory and labeling experience in Pharma Industry.
• Fluency in English (oral and written).

Aufgaben

• Creates and maintains Global Regulatory Product Information documents.
• Leads labeling-related activities within product teams.
• Coordinates responses to labeling-related questions from authorities.

Kenntnisse

Problem solving

Communication

Ausbildung

Pharmacist, chemist, biologist or similar

Jobbeschreibung

Berufsgruppe: Life Sciences (Naturwissenschaften)
Branche: Pharma

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)

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.