349020BR
Aug 08, 2022
Serbia/Monten.

Job Description

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic.
A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.

We are looking for curious, perseverant, and purpose driven candidate for the position of a Regulatory Affairs Manager to join Sandoz Serbia team – a dynamic and evolving organization. Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives? Join Sandoz!


Your key responsibilities:

As a Regulatory Affairs Manager you will have the responsibility of regulatory life-cycle management development and implementation and new registrations in the short and long term.


Major accountabilities:

• Maintenance of registered products with renewals and variations – with minimum supervision, evaluate, prepare and submit drug renewals/variation applications in a timely manner and follow through the application during the evaluation phase.
• Maintenance safety variations - preparation and submission drug variations applications in a timely manner
• Management of the regulatory documents/files/databases according to the possible highest quality
• New registrations - preparation and submission of assigned new registrations in a timely manner and follow through the application during the evaluation phase to achieve a positive outcome (including preparation of Module 1 according to local legislative and submission of registration dossier (Module 1-5) according to local legislation.
• Handling deficiency letters during evaluation phase
• Responsibility for the regulatory compliance for assigned products
• Obtaining ALIMS Import Permissions for samples or working standards for laboratory analyses in ALIMS
Artwork responsible for creation and maintaining of artwork database and activities needed for initiation of artwork updates/creation of packaging material and giving regulatory approval
• Obtaining import permissions for regulatory samples and working standards for registrations
• PSURs and RMP submissions tracking
• Regular reporting on Regulatory Affairs on time
• Ensure and support of new launches from regulatory side
• Maintenance of regulatory archive

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Requirements:
• University degree in pharmacy
• At least 3-5 years of experience in Regulatory Affairs in pharmaceutical company
• Strong team-oriented approach and supportive management style
• Country language
• English
SANDOZ
COMMERCIAL OPS EUROPE SZ
Serbia/Monten.
Belgrade
Research & Development
Full Time
Regular
No
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349020BR

Regulatory Affairs Manager

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