Regulatory Coordinator

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 include, but are not 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.

• Support the GPRD/GPRMs by:
o Timely delivery of HA submissions (e.g. variations, IND/IMPD (CTAs), NDA/MAA etc.) & HA queries.
o Regulatory Intelligence and other regulatory support information
o Timely completion of Module #1 in eCTD
o Regulatory deliverables met (i.e. support for briefing books, power-point presentations, excel spreadsheets, informal tracking for deliverables)
o Updating and marinating QPPV tracker
o 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
o NTO, Reg CMC, Global labelling & RA Ops for renewals
o SCM, Tech Ops for Regulatory samples.
o HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc.
o External Service providers

• Contribute for xEVMPD submissions to ensure :
o Quality of the data submitted to EMA
o Compliance by performing timely submissions and keep EVMPD database up to date with all the EVMPD relevant changes
o Analysis or/and implementation 3rd acknowledgements received following xEVMPD submission.
o 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:
o Tracking, monitoring and QC of each request for P& D and follows-up to resolve any inconsistencies identified.
o Working closely with GPTD and all other stakeholders (global BD&L; global Legal; CO Legal/Medical/RA) for smooth flow of P&D request.
o Preparing PD FLT pre-reads
o Maintaining P&D SharePoint (SP) up to date with all relevant information.
o Working closely with IT for P&D SP maintenance activities and P&D portal bug fixes.
o Handling CO’s P&D portal related queries.

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

• Independently manage the activities associated with external service providers. Maintenance of up-to-date country requirement lists and plans covering activities in scope through conducting need-based surveys & interaction with COs. Independently manage interaction & collaboration with RA colleagues in Country Organizations (COs) for regulatory maintenance activities. Provides support for internal/external audits/inspections. Proactively identify areas for process productivity and efficiency improvement & propose potential solutions.

Diversity & Inclusion / EEO

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

Minimum Requirements

• 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 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.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network