345653BR
May 20, 2022
India

Job Description

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:

• .Support regulatory compliance activities, including entering product specific attributes as
provided by program team representative into Regulatory Information Management System
(RIM) (e.g. DRAGON).

• Provide support as needed for routine Health Authority (HA) submissions including Annual
Reports, New Protocol Submissions, Protocol Amendment, Renewal, Production Transfer (PT)
Submissions (non-EU countries), New Product Planning (NPP) (non EU countries) etc. and as
applicable act as main liaison with RA Operations to ensure accurate and timely submissions to
HAs.

• 3. Support the GPRD/GPRMs by:
• Timely delivery of HA submissions (e.g. variations, IND/IMPD (CTAs), NDA/MAA etc.) &
HA queries.
• Regulatory Intelligence and other regulatory support information
• Timely completion of Module #1 in eCTD
• Regulatory deliverables met (i.e. support for briefing books, power-point presentations, excel
spreadsheets, informal tracking for deliverables)
• Updating and marinating QPPV tracker
• Subway related activities

• Support to planning and managing timely delivery of critical regulatory materials (registration
samples) and various regulatory authorized documents (certificates) for product license
renewals, manufacturing site transfers & new registration submissions in Most of the World
(MoW)/Latin America & Canada & Region Europe (non EU countries) and Greater China
regions (as per requirements).

• Support for procurement of various key regulatory components (e.g. ordering certificates, GMP,
registration samples, COA’s and other regulatory documents as per the need) to achieve
marketing authorization and life cycle maintenance in collaboration with following internal and
external stakeholders
• NTO, Reg CMC, Global labelling & RA Ops for renewals
• SCM, Tech Ops for Regulatory samples.
• HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc.
• External Service providers

• Contribute for xEVMPD submissions to ensure :
• Quality of the data submitted to EMA
• Compliance by performing timely submissions and keep EVMPD database up to date
with all the EVMPD relevant changes
• Analysis or/and implementation 3rd acknowledgements received following xEVMPD
submission.
• Ensure timely completion of all xEVMPD related activities like PSUSA fee note,
annual fee note etc.

• Support for P&D portal application and P&D related activities by:
• Tracking, monitoring and QC of each request for P& D and follows-up to resolve any
inconsistencies identified.
• Working closely with GPTD and all other stakeholders (global BD&L; global Legal; CO
Legal/Medical/RA) for smooth flow of P&D request.
• Preparing PD FLT pre-reads
• Maintaining P&D SharePoint (SP) up to date with all relevant information.
• Working closely with IT for P&D SP maintenance activities and P&D portal bug fixes.
• Handling CO’s P&D portal related queries.

• Support for divestment related activities by:
• Data collection during the early stages of potential divestments.
• Coordinating with CO for collection of regulatory data.
• Support to respective GPRMs, as needed, in the implementation phase.
• Handling RIM system (e.g. DRAGON) related activities.
• Co-ordinate with legalization team to get signed and legalized deceleration letter.

Diversity & Inclusion / EEO

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:
• Minimum of 2 years of pharmaceutical experience.Prior publishing/Regulatory Operations experience desired
• Good communication and negotiation skills .Proactive personality
• Fast and flexible, focused on timely delivery and stretch targets
• Ability to plan and prioritize workload for self and others
• Ability to work in a matrix environment across sites
• Ability to build effective relationships across teams/projects

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:

https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345653BR

Regulatory Coordinator- LCM

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