Global Program Regulatory Director

vor 3 Wochen

Kundl, Österreich Sandoz GmbH Vollzeit

**Global Program Regulatory Director (d/f/m), 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.

Join us as a Founder of our ‘new’ Sandoz

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

- Regulatory Strategy:

- Provide regulatory leadership to assigned project(s).
- Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
- HA Interactions:

- Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
- Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
- Submissions and Approvals:

- Lead the global submission planning process, including potential Advisory Committees.
- Lead regulatory submission process throughout project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response
- Managerial
- Effective matrix management of regulatory team(s) (indirect reports) consisting of GPRM’s and other DRA line functions, providing, to the extent possible, mentorship and opportunities for growth and development.

Diversity and Inclusion
- We are 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**:
**Essential**:

- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
- Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:

- Innovation in regulatory strategy.
- Prior history with post-marketing/brand optimization strategies and commercial awareness
- Major involvement in a CTD/MAA/NDA submission and approval.
- Leadership role in HA negotiations in multiple regions.
- Proven success in global drug regulatory submissions.
- Proven ability to analyze and interpret efficacy and safety data.
- Regulatory operational expertise.
- Fluency in English as a business language. Additional language is an asset.
- Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
- Global matrix management people management experience desirable.
- Good management, interpersonal, communication, negotiation and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.

**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. 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 € 80,433.64/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 competenciesWe are open for part-time and job sharing models and support flexible and remote working where possible.

Sandoz
- Division
- SANDOZ
- Business Unit
- Sandoz Global Development
- Location
- Austria
- Site
- Kundl
- Company/Legal Entity
- Sandoz GmbH
- Functional Area
- Research & Development
- Job Type
- Full Time
- Employment Type
- Regular
- Shift Work
- No

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