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Senior Associate Regulatory Affairs

Schaftenau, Austria
Closing date
Mar 19, 2023

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Other, Legal/Regulatory Affairs
Position Type
Full Time
Organization Type

Job Details

Job Description

Regulatory Affairs Associate (m/w/d)

8! This is the number of biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide while further biosimilars are under development.

As a Regulatory Affairs Associate (m/f/d) you contribute to bringing new biosimilars to the market as well as to keeping the marketing authorization for already approved products. You will be responsible for providing operational support for the compilation of biosimilar dossiers. You are interested in gaining regulatory knowledge related to drug development while bringing along a collaborative and patient-focused mind-set.

Your responsibilities include, but are not limited to:

• Support activities and documentation necessary for submissions and product maintenance worldwide throughout lifecycle of the product (incl. variations, renewals, Periodic Safety Update Reports, pruning).
• Manage the interaction with DRA colleagues in country organizations (COs) and with Sandoz agents where no CO exists
• Support implementation of prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. Health Authorities, COs).
• Support regulatory compliance activities, including operational support of relevant IT systems or databases.

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:

• Minimum Matura / Gymnasium / High School degree
• Good interpersonal and communication skills
• Ability to work effectively in a matrix environment in a multi-cultural setting
• Ability to plan and prioritize workload
• Proficient in English (oral and written)

Desirable requirements
• Strong communication and interpersonal skills.
• Ability to work in a team
• High accountability to independently complete tasks

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!

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €39,625.32 /year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

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:


At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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