Regulatory Affairs Manager

Vor 2 Tagen

Langkampfen T, Österreich Novartis Vollzeit

**(Senior) Regulatory Manager (f/m/d), Kundl/Schaftenau, Tyrol, Austria**

576 That is the total number of projects and products on our Global Regulatory Affairs CMC (Chemistry, Manufacturing, Control) project list. All of these innovative projects are aimed at making a difference in patients’ lives, and we need your help. As a member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for sophisticated projects and products covering development, registration and approval/post approval activities.**Your key responsibilities**:

- (Support to) formulate and drive global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance
- Supporting all 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.
- Lead, prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate
- Provide strategic advice within and outside of RA CMC, driving continuous improvement and building the talent within the team through coaching and mentoring

**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**:

- University Degree (BSc, MSc) in a relevant field (preferably in Life Science, Pharmacy, or business-related field)
- Previous experience in a related role is a plus
- Client-focused, strong planning negotiation and organizational skills
- Excellent verbal and written communication skills in English, German is a plus
- Ability to establish and maintain good and professional relationships with Key Accounts
- Possess high achievement drive and self-motivation

**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 € 54.799,30/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**
- Global Drug Development

**Business Unit**
- REG AFFAIRS GDD

**Country**
- Austria

**Work Location**
- Schaftenau

**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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