349258BR
Jul 20, 2022
Slovakia

Job Description

Great opportunity at no. 1 pharma company in Slovakia!
Regulatory Affairs Manager has the responsibility for all regulatory activities regarding the assigned part of the product portfolio in the Slovak Republic, ensuring compliance with all regulatory objectives and requirements. This role is also cross-functional and cross-divisional as this person would cooperate with the local teams such as Medical, Marketing, Quality, Logistics, Market Access and Pharmacovigilance and also with the global regulatory teams. This is a part-time (0,5 FTE) position.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• New submission, maintenance and deregistration of approved products within pre-defined timelines
• Submission and implementation of country-specific packaging materials as required for product maintenance and launches
• Regulatory compliance in safety issues (SLCs, RMPs, DHPCs)
• Reviewing promotional materials of the assigned part of the product portfolio.
• Maintenance of all regulatory relevant global/local databases
• Collaboration with other departments in line with the local, regional and global strategies
• Ensuring legal and ethical conduct, corporate compliance and adherence to company guidelines and procedures

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• University degree in Medicine, Pharmacy, Natural Science, Chemistry
• Proficient Slovak
• Proficient English
• Proven experience working in Regulatory Affairs

You’ll receive:
The minimum salary offered is starting at 14 400 Eur yearly along with a huge variety of benefits. The final salary depends on the experience of the candidate.

Why consider Novartis?
766 million lives were touched by Novartis in 2021, and while we’re proud of this, we know there is 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 the courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greater risk in life is the risk of never trying!

Imagine what you could do here at Novartis!

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
Global Drug Development
REG AFFAIRS GDD
Slovakia
Bratislava
Research & Development
Part Time
50
Regular
No
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349258BR

Regulatory Affairs Manager

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