Regulatory Manager RCC APAC (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (bei München)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 240453BR


Stellenbeschreibung

The Regulatory Competency Center Manager is responsible for the preparation and submission of new innovative/generic products in the Asia Pacific region. This role provides strategic guidance and direction to Sandoz Development and Maintenance Centers, ComOps, Third party development teams and acts as a primary interface between Sandoz Country Organizations and Sandoz Global functions.

• In collaboration with Sandoz Development and Maintenance Centers, the RCC-Manager is accountable for the preparation of the administrative part of the regulatory dossier Module 1 and supports DLMRC for Module 2-5 dossier preparation, ensuring each molecule has a defined regulatory strategy and in full compliance with government regulations.
• Participate in the development and implementation of local and regional regulatory strategy with Sandoz Development & Maintenance Centers and international partners.
• Coordinate internal and external regulatory inquires and response strategy for deficiency letters in close collaboration with country organizations.
• Accountable for the timely approval and launch of Sandoz products in assigned markets.
• Preparation and review of variation packages to assigned markets.
• Monitor and evaluate changes in local and regional regulations for regulatory impact on development projects and ensures commercial feasibility of regulatory strategy.
• Participate in local and regional meetings, working as a business partner between Sandoz global functions and country organizations.
• Maintenace of regulatory tracking and compliance databases/ tracking tools.



Research & Development


Mindestanforderungen

• Pharmacist, bachelor’s degree in Chemistry, Biochemistry, Pharmacology, or other relevant disciplines. Advanced science degree preferred.
• Minimum 1-2 years regulatory experience and/or pharmaceutical industry experience.
• Knowledge of drug development process and ICH guidelines.
• Project management and organization skills.
• eCTD experience would be an asset.
• Fluent in English (spoken, written and presentation)
• German and other languages would be an asset
• Good knowledge of Microsoft Office Suite.



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