Regulatory Affairs IM&S TS Specialist – Novartis Farmacéutica – Almere Stad

Novartis Farmacéutica

500 Million! Sandoz is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to discover new ways to improve and extend people’s lives, in driving access to medicine worldwide. Every year, our products reach approximately 500 million patients.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Support regulatory teams during the submission process in all administrative and technical steps according to global procedures;
• Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements;
• Ensure eCTD lifecycle maintenance according to ICH and regional specifications;
• Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant;
• Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates;
• Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents;
• Ensure escalation procedures are followed in case of issues and delays;
• Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness;
• Might be involved in document bulk upload activities.

Diversity & Inclusion / EEO

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

What you’ll bring to the role:
• University or College Degree in any field or life science with relevant industry experience or comparable degree;
• At a minimum 2 years’ experience in the pharmaceutical area, specifically in Regulatory Operations;
• Good communication in English (oral and written);
• Ability to work under pressure, demonstrating initiative and flexibility;
• High level understanding of Regulatory quality, standards and policies;
• Attention to detail and quality focused;
• Team-minded.
Desirable Requirements:
• Dutch speaker;
• Experience in the Regulatory submission publishing, area;
• Organizational awareness and experience working cross-functionally and in global teams.

What we can offer:
Competitive salary, annual bonus, pension scheme, voluntary contribution collective health insurance, 27 days annual leave, paid parental leave, flexible working arrangements, home office allowance, employee recognition scheme, bike scheme.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz!

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

Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Information:
For more information about the position, please contact the Staffing Center via [email protected]

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