Regulatory Affairs Manager (m/f/d) - (1 Year Contract)

About the role

Regulatory Affairs Manager (m/f/d), Sandoz, 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!

Your key responsibilities:

Your responsibilities include, but are not limited to:

• You have an important role in evaluating regulatory requirements and providing regulatory strategies when preparing or managing the timely delivery of high quality documentation required for clinical trials, initial marketing authorization applications and dossier reviews worldwide

• You know how to handle regulatory risks: you proactively identify and highlight potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations

• You provide input and collaborate with relevant stakeholders when you focus on implementing strategies, ensuring timelines and formal requirements, or assuring congruency and compliance

• You are an active member of the regulatory project (sub)team and where applicable, may act as representative of regulatory functions in the global project team(s)

• You lead the preparation of responses to regulatory relevant queries from various stakeholders and you directly interact with regulatory authorities and/or with regulatory functions in the countries

Role Requirements

What you’ll bring to the role:
Essential Requirements:

• An advanced degree in life sciences/healthcare (PharmD/PhD) or relevant industry experience · 2-3 years experience in regulatory affairs in a pharmaceutical/biotech company

• Good understanding of US FDA regulatory requirements for drug development. Experience with other Health Authorities a plus

• Advanced ability to interpret scientific data and to construct persuasive regulatory documents

• Good communication skills, ability to work effectively in a matrix setup

• Ideally, experience in leading functional subteams

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 € 60,212.18 a year (on a full time basis). The actual salary will be significantly 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.

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:

#Sandoz

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.