Regulatory Affairs Manager; Biosimilars (d/f/m)

Job Description Summary

Job Description

Regulatory Affairs Manager; Biosimilars (d/f/m)

Biosimilars, Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

This is a full-time position located in Kundl, Austria.

50% office presence is preferred.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Life Cycle Management of Biosimilar products registrations (new registrations, variations, PSURs and renewals) in EU, US, international region (80+ countries)

• Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates worldwide

• Communication with Health Authorities (HAs), where applicable

• Develop and implement plans for timely response to HA requests and coordinate responses

• Drive coordination, planning, and submission of dossiers in assigned regions worldwide

• Review of global dossier summary documents

• Partner with regions to align on regulatory strategy in order to fulfil business objectives

• Act as representative of regulatory functions in cross-functional project teams and workstreams

What you’ll bring to the role:

Essential Requirements:

• University degree in a life science (e.g. pharmacy, chemistry, biology or similar) ideally PhD or comparable qualification

• Minimum 2 years work experience in the pharmaceutical or biotech regulatory affairs

• Self-organized, structured way of working, high quality awareness, proven team player

• Good communicator

• Ability to interpret scientific data and to construct persuasive regulatory documents

• Ability to work in an environment with changing priorities

• Proficiency in English (oral and written)

• Knowledge of Microsoft Office

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Imagine what you could do here at Sandoz!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. 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 € 64.023,54/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

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

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search | Sandoz

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Skills Desired