Regulatory Affairs Specialist

hace 2 semanas

Ciudad de México Novartis A tiempo completo

Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross-functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With a strong medicines pipeline, our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.Your responsibilities:Your responsibilities include, but are not limited to:- Coordinates and prepares high quality submissions of regulatory dossiers for assigned products (post approval changes & New Drug Applications).- Ensure license renewal Submission and approval on time.- Assist to coordinate face 2 face meeting with cross functional areas for project discussion.- Communicate the questions referred by HAs timely and smoothly.- Timely update and communicate the registration status to the line manager.- Timely order and tracking the registration documents, dossier, certificates. etc.- Provide regulatory support for other functions (marketing, medical, access, supply chain)- Start to establish good communication and relationship with key stake holders.**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._**Minimum requirements**What you’ll bring to the role:- Complete degree in life science or related.- Minimum 1 year of experience in the Regulatory Affairs area in the pharmaceutical segment.- English Intermediate- Spanish FluentWhy consider Novartis?766 million lives were touched by Novartis medicines in 2021, 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 tryingImagine what you could do here at Novartis**Division**Global Drug Development**Business Unit**REG AFFAIRS GDD**Country**Mexico**Work Location**Ciudad de México**Company/Legal Entity**NOV CORPORATIVO MEX**Functional Area**Research & Development**Job Type**Full Time**Employment Type**Regular**Shift Work**No**Early Talent**Yes

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