Associate Director Regulatory Affairs Austria (D/W/M)

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:

Team and culture

• Leads, develops and manages the RA department

• Sets objectives, reviews progress, manages and coaches direct line reports

Compliance:

• Ensures Regulatory Compliance and Governance

• Defines overall standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations.

• Oversees implementation of the relevant (local) procedures, and record management.

• Evaluates impact and anticipate future trends, implications of important emerging guidelines and changes in political environment, which are likely to affect Sandoz’ interest.

• Represent RA during internal and external audits and health authority inspections at country level.

Activities to support Sandoz and our customers:

• Leads the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant)

• Accountable for creation & translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)

• Accountable for timely implementation of changes of the registered text into artworks

• Leads timely provision of regulatory advice on strategic and tactical options to achieve earliest acceptance of registration applications, launches and transfers

• Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units and Portfolio & Launch, Medical)

• Leads, develops and maintains good relations with Sandoz Global Regulatory and other Sandoz RA country organizations

• Leads working interface with key internal and external stakeholders. Represent Sandoz at trade organizations and at health authorities regarding (changes in) regulatory affairs legislation.

• Leads, manages and undertakes regulatory across the Medical/Marketing/Market Access/QA/PS interface

• Plays an active role in the local launch team to achieve the company’s business objectives

• Acts as Sponsor and Contributor to relevant local and global business initiatives to ensure DRA is seen as a “Best in Class” organization. Drive process optimization for operational excellence and set priorities for the team.

• Ensures Regulatory Compliance for all registered products, in close cooperation with the QA department

• Ensures that all relevant Key Performance Indicators (including Safety label Changes, Artwork, Checklists, Deviations, RA input in RMP implementation and DHPC communication, are achieved timely & correctly

What you’ll bring to the role:

• University Degree, preferable Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.

• Min 5 year relevant work experience

• Extensive experience in the pharmaceutical industry (> 5 years)

• Strong leadership skills

• Ability to develop and manage direct line reports

• Ability to manage operational and strategic workload

• Understanding and experience of risk management

• Understanding and experience with process optimization

• Fluent in German and English (written and oral)

• Stakeholder management

• Planning, organizational skills and eye for detail Strong written communication skills

• Leadership skills

• Prioritization and decision taking

• Result oriented

• High ethical standards

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, 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 € 77.543,90/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.

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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