Expires soon SANDOZ

Regulatory Affairs Project Head

  • Moscow, Россия
  • Legal

Job description

Job Description

-All the registration activities (marketing authorisations) on Novartis Pharma products are prioritised and conducted according to plans and resources.
-Current regulatory legislation and guidelines in Russia are kept up to date.
-All imported Novartis Pharma products are handled qualitatively correct and in accordance with the approved marketing authorisations.
-Registration activities are planned and reported to local management as well as global line function.
-DRA a personnel is leaded, motivated, supervised, developed and coached.
-Targets for DRA personnel are set and their performance evaluated.All the requirement of National Guidelines and Pharmacovigilance criteria in National -Novartis Product information are met.
-Challenging Health Authorities (low and middle level) for their operational system development (lobbying functions)
Position Title

Regulatory Affairs Project Head

Desired profile

Minimum requirements

-Degree in Medicine, Pharmacy, Biology or Chemistry
-English: Fluent spoken & written
-2-3 years experience in clinical regulation and management of clinical approval processes
-Clear and full understanding of relevant pharmaceutical regulation

What we offer for you:

• Competitive salary and annual bonus level
• Medical insurance (for the employee and children, additional discount given for close relatives)
• Life insurance, meal allowance, mobile compensation;
• Flexible working hours and 2 possible home office days monthly;
• Internal and external educational courses and trainings;
• Additional 3 additional days of paid vacation;
• Professional and career development opportunities (locally as well as worldwide).

Why Novartis:

927 million lives were touched by our products last year, and while we are proud of that we must ask ourselves: in this world of rapid digital and technological transformation, how will we reimagine medicine and continue to bend the curve of life?
We believe the answers are found when curious, courageous and collaborative minds like yours are brought together in an inspiring environment. Where you are given the opportunity to explore the power and potential of data and digital. Where you’re empowered to risk failure by taking smart risks. Where you’re encouraged to share new ideas that’ll open up new ways of making things happen, and where you’re surrounded by teams who are equally determined to transform lives by tackling the world’s toughest medical challenges.
Join Novartis and help us reimagine medicine.
Job Type

Full Time
Country

Russian Fed.
Work Location

Moscow
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

REG AFFAIRS GDD
Employment Type

Regular
Company/Legal Entity

OOO Novartis Pharma

Make every future a success.
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