Regulatory Affairs Manager

Aug 30, 2021

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. We are looking for curious, innovative, driven people to contribute to Sandoz success story in biosimilar development and help us get new biosimilar products into the market to improve access for patients. Maybe that’s you.

Your responsibilities include, but not limited to:

• You have an important role in evaluating regulatory requirements and providing regulatory strategies when preparing or managing the timely delivery of high quality documentation required for worldwide Health Authority meetings, clinical trials, initial marketing authorization applications and dossier reviews
• You know how to handle regulatory risks: you proactively identify and highlight potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
• You provide input and collaborate with relevant stakeholders when you focus on implementing strategies, ensuring timelines and formal requirements, or assuring congruency and compliance
• You are an active member of the regulatory project (sub)team and where applicable, may act as representative of regulatory functions in the global project team(s)
• You lead the preparation of responses to regulatory relevant queries from various stakeholders and you directly interact with regulatory authorities and/or with regulatory functions in the countries

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

Minimum Requirements

What you will bring:
• An advanced degree in life sciences/healthcare (PharmD/PhD) or relevant industry experience
• 3 years experience in regulatory affairs in a pharmaceutical/biotech company
• Good understanding of US FDA regulatory requirements for drug development and experience with direct liaison with FDA. Experience with other Health Authorities a plus
• Advanced ability to interpret scientific data and to construct persuasive regulatory documents
• Good communication skills, ability to work effectively in a matrix setup
• Ideally, experience in leading functional subteams

799 million. That’s how many lives our products touch. 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?
BioPharma SZ
East Hanover, NJ
Research & Development
Full Time
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Regulatory Affairs Manager

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