Executive - Regulatory Affairs

1 month ago

Mumbai, India Novartis Full time

1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family.
Your responsibilities include, but are not limited to:

- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
- Contribute to strategic and technical input /support to drive implementation of global

systems, tools and processes to support global development projects and/or marketed
products.
- Write, edit and /or manage the production of high quality clinical documentation (e.g.

Clinical Study Reports & Summary Documents) for submission to regulatory authorities in

Developing professional expertise, applies company policies & procedures to resolve a
variety of issues. Frequent internal company and external contacts. Represents organization on specific projects
- Works on problems of moderate scope where analysis of situations or data requires a review

of a variety of factors.
- Refers to established policies & procedures for guidance.
- Contributes to some cost center goals & objectives. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable)

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- 2+ years of relevant experience in Data Science
- Collaborating across boundaries
- Cross Cultural Experience
- Functional Breadth
- Operations Management and Execution
- Process management, Project Management, Technical knowledge
- Working experience within the pharmaceutical industry

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

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.

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

India

**Work Location**

Mumbai

**Company/Legal Entity**

Nov Hltcr Shared Services Ind

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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