Job title: Manager , Maintenance Regulatory Center (MRC)
Company: The Medicines Company
Job description: 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. Y
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: . Life cycle management of Marketing Authorizations (MAs). Core experience in new submissions and life cycle management in major markets EU/US/CAN/JP/AUS/BR/CN will be an added advantage. New submissions in Most of World (MoW) regions and its planning as per targets . Responsible for MA transfers and maintaining product history as per defined timelines and processes.Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. . Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.Experience of handling worksharing and supergrouping variations strategy. . Prepare CMC responses to health authority questions during development, registration and product lifecycle. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc) for possible regulatory impact. Experience on managing administrative changes will be an added advantage.Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. . Experience of managing QP declarations, GMP certificates, CEPs, Import permissions, COPP, legalizations, Apostille, translations, sample management as per global regulatory requirement.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. . Keep knowledge upto date with regard to regulatory guidelines and requirements in all regions as well as for new technical trends.Actively participate as a member of the global RegCMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. . Establish and maintain sound working relationships with partners, stakeholders and customers.Assume activities in support of the global databases and quality systems.Interactions with Health Authorities as and when required as per business requirements.Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management) [#video#https://www.youtube-nocookie.com/embed/Mo1vwtVPVA0#400,300##/video#] Minimum requirements What You’ll bring to the role: . Minimum 12+ years of experience in core Reg CMC areas. . Good team player and teamwork.Good regulatory drafting skills . Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload . Post Graduate in Pharmacy or Science (e.g. Analytical chemistry) or equivalent,Additional courses in Drug Product Regulatory Affairs would be added advantage . Effective planning, organizational and interpersonal skills. . Excellent written and spoken – communication and negotiation skills . Reasonable approach to risk assessment . Good computer skills and typing speed Why 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 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 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
Location: Hyderabad, Telangana – Secunderabad, Telangana
Job date: Thu, 14 Jul 2022 22:15:36 GMT
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