Executive- Ra Gdd

Job Description:

- 200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
- Your Responsibilities:

- Your responsibilities include but not are 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.- 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

**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:
- 2+ years of relevant experience in Data Science.Collaborating across boundaries.Adherence to Novartis policy and guidelines.Project & stakeholder feedback
- Assist Head RA, GDD /Manager for regulatory intelligence; as appropriate.Compilation- Pharma products.- Compilation and HA submission of Clinical Trial Application (CTA)

dossiers for GDO projects as per defined timelines along with their compliance activities
- Novartis India Public Affairs for monitoring progress to take next actions steps as
- appropriate in consultation with RA, GDD Manager/ Head.- Maintenance of compliance activities like PSUR, Post approval changes like CMCs of imported products and their HA submissions.
- Maintenance of on-going CT projects: Independently, ensure various regulatory

compliances related to the clinical trial projects from submission to study completion.- Interact with local GDO group for finalization of texts related to clinical trial

consignment labels / licenses and ensuring that the same are implemented for timely and
- smooth clearance of clinical trial materials.- Review of protocol, investigator brochure,IMPD documents and entire clinical trial package and coordinate with local GDO group to ensure completeness for timely HA submission.

Why consider Novartis?
- 799 million. That’s how many lives our products touch. 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**
- 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