338411BR
Feb 17, 2022
Switzerland

Job Description

Regulatory Affairs Manager, Novartis, Basel, Switzerland


1 unique opportunity to join Regulatory Affairs Team!

Person on this position will take care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swiss medic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.
This role is limited for 2 years

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Preparation of the regulatory strategy for new submissions
• Timely submission of new products to Swissmedic in agreement with the yearly target
• Obtain a number of marketing authorizations in accordance with the yearly target
• Drive product maintenance to ensure regulatory compliance.
• Provide close regulatory support to the Marketing, Medical, Market Access and Commercial departments.
• Strategic business partner to Launch, Portfolio, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs, MRC, BDRA)
• Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time

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

What you’ll bring to the role:
• At least 3-5 years Regulatory experience, experience in Biosimilars of advantage
• A strong team player who gets to the front, flexibility in a changing environment and ability to
• Experience and know-how in Drug Regulatory Affairs and project management.
• Knowledge of Swiss regulations and guidelines.
• Know how on Quality Assurance and Pharmaceutical Technology.
• Visionary and future-oriented mindset, continuously challenging the status quo to achieve overall business targets


Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

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
SANDOZ
COMMERCIAL OPS EUROPE SZ
Switzerland
Basel
Research & Development
Full Time
Temporary
No
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338411BR

Regulatory Affairs Manager

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