Registration Manager

vor 3 Wochen

Kundl, Österreich Sandoz Vollzeit

1500 The average number of new submission Regulatory Affairs (Sandoz Small Molecule) does per year.
- 3 billion USD This is the pipeline value of products developed in Kundl (L+5y sales forecasts). Global - the name of the market for which the registration manager will be preparing regulatory strategies enabling early patient access to affordable medicines.
- Your key responsibilities:
- Contribute as Development Regulatory Center (DRC) Manager Chemistry, Manufacturing and Controls (CMC) expert to technical project teams during product development
- Ensure alignment across global and local functions with regard to strategy and direction for timely preparation of high quality CMC documentation to support new regulatory submissions for complex new product developments and/or for a portfolio of new product development projects
- Independently and proactively identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
- Write high-quality CMC documentation according to agreed CMC regulatory strategies, while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products world-wide
- Manage/lead DRC related projects or global initiatives

**Commitment to Diversity & Inclusion**:

- Novartis is 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:
- Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
- At least 3 years’ experience in Regulatory Affairs (with a focus on knowledge of CMC requirements)
- Develops and presents strategic regulatory options to internal and external stakeholders
- Demonstrates strong leadership skills, establishes (cross-functional) teams/relationships and maintains them
- Very strong communication skills in English

Why Novartis?
- 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis
- 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 within the Novartis group. 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 € 54.788/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.Commitment to Diversity & Inclusion:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
- Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.**Division**
- SANDOZ

**Business Unit**
- Sandoz Global Development

**Country**
- Austria

**Work Location**
- Kundl

**Company/Legal Entity**
- Sandoz GmbH

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Temporary

**Shift Work**
- No

**Early Talent**
- No

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