Ra Cmc Senior Manager Biosimilars

vor 5 Monaten

Kundl, Österreich Sandoz GmbH Vollzeit

**Regulatory CMC Senior Manager Biosimilars (M/F/d), Kundl, Tyrol, 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.

This is a 2-year fixed term contract role with the possibility to be transferred into a permanent position.

Join us as a Founder of our ‘new’ Sandoz

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for biosimilar products.
- Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
- Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
- Initiate and lead Health Authority interactions and negotiations.
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**What you’ll bring to the role**:

- Good oral and written communication skills with a collaborative and patient-focused mindset
- Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
- Well-developed planning, organizational, negotiation, problem solving and interpersonal skills.
- Computer/IT systems literacy.

**Essential requirements**:

- Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent with oral and written fluency in English.
- Ideally, at least 2 years’ experience in regulatory and/or in the pharmaceutical industry; working knowledge in regulatory submissions desirable.
- Demonstrated working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Ability to critically evaluate data from a broad range of scientific disciplines.

**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.

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. GJFA 1-4: 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 Euro/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.

Sandoz

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