Regulatory Affairs Associate Job at Sandoz in Madrid, Madrid provincia
108,000! That’s the number of associates whose lives we touch and improve. As a Regulatory Affairs Associate you will contribute to the effectiveness of the regulatory affairs team. new product registration and maintenance activities for the existing products.
Your responsibilities include, but not limited to:
- Manage medium to small level global regulatory submission projects
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products
- Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products
- Write, edit and/or manage the production of high quality clinical documentation (e.g. Clinical Study Reports and Summary Documents) for submission to regulatory authorities in support of marketing applications
- Develop professional expertise, apply company policies and procedures to resolve a variety of issues
- Frequent internal company and external contacts. Represents organization on specific projects
- Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors
- Refers to established policies and procedures for guidance
What you’ll bring to the role:
- Graduation in any kind of life science. Master Degree in DRA or Pharmaceutical Industry
- Fluent in English and Spanish
- 2-5 years of DRA experience Module 1 and procedural regulations
- Launch preparation Reporting Authority contact Communication; also internationally and cross-functionally
- Handling of new submissions and variations
You’ll receive: Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
COMMERCIAL OPS EUROPE SZ
Sandoz Farmacéutica, S.A.
Research & Development
Company Location: Madrid, Madrid provincia