Regulatory Affairs Manager

vor 2 Wochen

Rotkreuz, Schweiz Sandoz Vollzeit

1 unique opportunity to join Regulatory Affairs Team
- You will be responsible for all drug regulatory affairs matters regarding the assigned indication group and be the interface between global Regulatory Affairs departments and Swissmedic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.
- Key Responsibilities:
- Preparation of the regulatory strategy for new submissions
- Timely submission of new products to Swissmedic in agreement with the yearly target
- Obtain a number of marketing authorizations in accordance with the yearly target
- Drive product maintenance to ensure regulatory compliance.
- Provide close regulatory support to the Marketing, Medical, Market Access and Commercial departments.
- Strategic business partner to Launch, Portfolio, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs, MRC, BDRA)
- Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time

**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:
- Qualified Pharmacist or natural scientist preferably with medical background.
- German (fluent), English (advanced)
- 3+ years experience in Regulatory Affairs
- Organisation of new submissions and product maintenance in due time.
- Experience and know-how in Drug Regulatory Affairs and project management.
- Knowledge of Swiss regulations and guidelines.
- Know how on Quality Assurance and Pharmaceutical Technology.

Desirable Criteria- Biosimilars of advantage
- French & Italian Ianguages

Why Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? 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 Sandoz
- Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**
- SANDOZ

**Business Unit**
- EUROPE SZ

**Country**
- Switzerland

**Work Location**
- Rotkreuz

**Company/Legal Entity**
- Sandoz Pharmaceuticals AG

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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