Job Description

About the role

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:

o Integrate regulatory maintenance strategy into product development activi\xc2\xad ties through participation in GPT/TSST/GBT RA Sub-Teams as needed.
o Coordinate timely and high quality preparation of all necessary documenta\xc2\xad tion by internal or external experts for Most of world, LACan including Canada, Region Europe (non EU countries) and Greater China License re\xc2\xad newals, Production Transfers.
o Work as Project Lead with the New product planning team/GPRM/GPRD as applicable to ensure deliverables are met timely as per the submission strategy based on product portfolio for New Chemical Entities/Line exte
across Most of world, LACan including Canada, Region Europe (non EU countries) and Greater China Regulatory activities related to assigned global portfolio brands:
o Assist GPRM/GPRD/GT AL to provide RA input and collaboration with rel\xc2\xad evant GLFs (Global Marketing, BD&L, RA-GL, RA-Regions, Reg-CMC, CD&MA, Patient Safety) in creation of regulatory strategies and action plans to maximize the value of assigned global portfolio brands world-wide in line with commercial goals and regulatory commitments.
o Provide RA inputs in responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned brands.
o Assist Manager/Sr. Manager in implementation of agreed actions relating to the thorough and efficient management of regulatory procedures across Most of world, LACan including Canada, Region Europe (non EU coun\xc2\xad tries) and Greater China.
o Assist Manager/Sr. Manager in evaluation and implementation of produc\xc2\xad tion transfers, in- and out-licensing initiatives for assigned Global portfolio brands, world-wide.
o Collaborate with relevant GLFs in creating and implementing strategies and action plans to ensure the maintenance of product licenses for assigned Global portfolio brands for assigned countries.

Role Requirements

• University Degree in Life Sciences, Pharmacy or Med\xc2\xad icine
• Fluency in English as business language,
• additional European languages advantageous
• 5-8 years of experience in regulatory affairs, related areas of the pharmaceutical Industry or Health Authorities

• Good interpersonal and communication skills, ability to work effectively in a matrix environment

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

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

REG AFFAIRS GDD

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis