Manager, MRC (Maintenance Regulatory Centers)

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.Prepares and implements regulatory maintenance activities and second wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that preparation of variations follow established processes and timelines. Acts as strong business partner and project team member for maintenance/compliance matters. Builds strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.Your Responsibilities:Your responsibilities include but not are limited to: Preparation of regulatory maintenance submissions, variations, renewals and second wave submissions, Modules 2 to 5. Effectively handles submission preparation to ensure implementation dates of variations and file availability dates of second wave submissions are met. Evaluates proposed changes and provides regulatory input for worldwide regulatory impact. Contributes to performance and KPIs of the team to deliver agreed targets and objectives and supports reporting. Provides DRCs/MRC sites/BD Regulatory, manufacturing business units with proper data and change evaluations to plan and implement registration activities and to meet commitments and requests of deficiency letters. Ensures that the partner concern process to higher-level management is followed, as applicable. Handles deficiency responses and rejections. Provides regulatory consultancy for products and NTO Ensures the receipt of accurate product transfers from DRCs and BD Regulatory. Ensures accurate data management.Minimum requirements What You ll bring to the role: Masters and or Ph.D/ Scientific degree, preferably in science (chemistry, pharmacy, biology or equivalent) Good written and spoken English. At least 8 years of proven experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Sophisticated project management skills Well-structured, result oriented, highly self-committed, resilient, flexible, team player Ability to provide strategic guidance to the stakeholders High level understanding of Regulatory quality, standards and policies.Why consider Sandoz Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.Imagine what you could do 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 :
project managementaccessregulatorymanagementmaintenance activitiesstrategyinnovationbusinesscareer opportunitiessciencerenewalscompliancebiologybusiness unitscontinuous improvement facilitation