Global Reg Submission Publishing Associate

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
- We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.
- Your Responsibilities:

- Your responsibilities include but not are limited to:
- Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high quality submissions.
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.

**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:
- 3-5 years submission publishing experience in Pharma or related industry.
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Works independently and with mínimal supervision.
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
- Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams.

Why consider Novartis?
- 769 million. That’s how many lives our products touched in 2020. 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.
- 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**
- Global Drug Development

**Business Unit**
- REG AFFAIRS GDD

**Country**
- India

**Work Location**
- Hyderabad, AP

**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