Manager RCC APAC (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Temporary
StellenID 254748BR


Stellenbeschreibung

• Be responsible for the preparation and submission of new innovative/generic products in the APAC region.
• This role provides strategic guidance and direction to Sandoz Development/Maintenace Centers, ComOps, Tech.Ops, Third party development teams and acts as a primary interface between Sandoz Country Organizations and Sandoz Global functions1
• 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.
• Maintenance of regulatory tracking and compliance databases/ tracking tools.



Research & Development


Mindestanforderungen

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacology, Pharmacy or other relevant disciplines. Advanced science degree preferred.
• Fluent in English (spoken, written and presentation); German and other Asia Pacific languages would be an asset
• Minimum 2-3 years regulatory experience and/or pharmaceutical industry experience, preferably worldwide with generic focus
• Knowledge of drug development process and ICH guidelines.
• Project management and organization skills.
• eCTD experience would be an asset.
• Good knowledge of Microsoft Office Suite


We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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