RA CMC Associate Manager-II

  • Hyderabad
  • Novartis
Job Description26 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:• Author high quality global CMC documentation for Health Authority submission throughoutthe product lifecycle, applying agreed CMC global regulatory strategies, current regulatorytrends and guidelines.• Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.• Identify the required documentation and any content, quality and/or timeliness issues forglobal submissions and negotiate the delivery of approved technical source documents inaccordance with project timelines.• As needed, coordinate /collect /store source documentation needed for direct submission toHealth Authorities.• Actively participate as a member of the global RA CMC team by contributing to theregulatory strategy, identifying the critical issues and lessons learned.• Perform activities in support of the overall department such as data entry into theRegulatory Information Management System, other CMC database entry, or maintenance andoperational activities as needed.• Reporting of technical complaints / adverse events / special case scenarios related toNovartis products within 24 hours of receipt• Distribution of marketing samples (where applicable) Diversity & Inclusion / EEO Minimum Requirements • Ability to work and lead (a cross-functional team) in a matrix environment.• Accountability, Collaborating across boundaries.• Cross Cultural Experience• Functional Breadth, Managing Crises• Operations Management and Execution• Project Management• Strong customer orientationWHY NOVARTIS769 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: