Global Program Regulatory Manager

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.- Your responsibilities will include:
- Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
- Provide input into global regulatory strategy and contribute to Regulatory Functional Plan (RFP) and Seed Documents, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partner with regions to align on regulatory strategy in order to fulfil business objectives. Implement RFP across assigned regions.
- Facilitate preparation and finalization of briefing books and contribute to preparation of summary documents.
- Develop and implement plans for timely response to HA requests and coordinate responses. May serve as local HA liaison depending on location (e.g., FDA or EMA).
- Coordinate, review, submit Clinical Trial Applications (CTAs) and Amendments.
- Lead key maintenance activities for approved products for your assigned region including the coordination and submission of variations, periodic safety update reports, RMPs. Support line extension submissions.
- May lead negotiations for regional approvals independently or with RA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL.

**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:
- Experience in working with cross-functional teams across different cultures in a virtual environment
- Excellent communication skills, both verbal and in writing
- Fluency in English
- Experience in coordinating Clinical Trial Applications for multi-national clinical studies
- At least 1-2 years of experience in Regulatory Affairs for development and marketed products, preferably in respiratory indications (asthma, COPD)
- University degree in life sciences. PharmD, PhD or MD is an asset.

Why consider Novartis?
- 799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at Novartis
- Commitment to Diversity & Inclusion:

- Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.-
**Division**
- Global Drug Development**Business Unit**
- REG AFFAIRS GDD**Country**
- Switzerland**Work Location**
- Basel**Company/Legal Entity**
- Novartis Pharma AG**Functional Area**
- Research & Development**Job Type**
- Full Time**Employment Type**
- Regular**Shift Work**
- No**Early Talent**
- Yes