May 26, 2023

Job Description

We are looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative.

As Regulatory Affairs Technician you will ensure a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.

You will be responsible for the compliance to the requirements from regulatory agencies and maintains the technical and non-technical documentation change system. You will also assure procedures are in place to classify and maintain records and interpret and enforce all documentation formatting, standards, policies, and operating procedure requirements. 

Major accountabilities:

•Preparing registration documentation for Health Authorities and customers ensuring that it follows the applicable regulations of each country. As well as ensuring consistency between and across the different elements of the registration document to be sent to Health Authorities and/or clients. Not to forget considering previous commitments with the Health Authorities in reference to the new registration document to be submitted.
• Evaluating in regulatory terms of the changes proposed by the company.
• Actively participating in new company projects that require your involvement, along with supporting the Registration Units (DRC/MRC/CO-DRA) of Sandoz and external customers by answering technical registration questions.
• Participating in any relevant working group at Novartis company group level, together with collaborating with direct supervisor, and other departments.
• Establishing good internal and external communication channels and ensure communication is effective.
• Ensuring the execution of assigned tasks according to assigned deadlines. In addition to immediately communicating to the direct supervisor the non-conformities detected in the procedures and any other incident that must be communicated and open the corresponding deviation when applicable.
• Reporting periodically to your direct supervisor the defined indicators related to the products under your responsibility to be able to report to the Global DRA API/AI function.
• Ensuring the correct status and update of registration documentation required to be reviewed in inspections by health authorities, corporate and customers, not to forget ensuring proper archiving of product documentation under your responsibility.

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:

• Grade Bachelor's degree in Science (e.g. Chemistry, Biochemistry, Pharmacy, Biology, Biotechnology) or equivalent.
• Minimum 5-year experience in the Pharmaceutical Industry in Regulatory Affairs positions
• Team orientation
• Sound organizational skills and initiative.
• Previous experience working on projects and according to KPIs/objectives.
• Fluent in English (oral and written), Spanish knowledge represents an advantage.

Desirable requirements:

• 1-year experience in positions related to aseptic processing.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 
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!


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
Anti-Infectives STO
Barcelona Palafolls
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Regulatory Affairs Technician

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