Specialist , IM&S

Job Description

1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.Your Responsibilities:Your responsibilities include but not are limited to: Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. Maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. Handles medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and implements all documentation formatting, standards, policies, and operating procedure requirements. EEO Statement 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: University or College Degree in any field or life science with relevant industry experience or comparable degree At a minimum 2 years experience in the Pharmaceutical area, specifically in Regulatory Operations Experience in the Regulatory submission publishing, area is preferred. Knowledge of Regulatory guidelines for the areas mentioned above Organizational awareness experience working cross-functionally and in global teams is a plus Ability to work under pressure, demonstrating initiative and flexibility Attention to detail and quality focused Team-mindedWhy Sandoz 500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.How will we do this 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 whats 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 Sandoz!Commitment to Diversity & Inclusion:Sandoz, a Novartis company, 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 Group 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,

Keyskills :
global teamsdigital conversioncareer opportunitiesdevelopment projectsregulatory guidelinessummarizing informationeeoriskaccesssciencerecordsstrategypressureretentionabstractsregulatory