Associate Director - Regulatory Publishing

Associate Director – Regulatory Publishing Job Description Managing end-to-end Publishing support for initial IND/NDA/MAA/BLA applications and Lifecycle maintenance of all applications across US/CA/UK/EU and GCC regi on Also manage day-to-day operations using project management and planning tools, create and maintain detailed project timelin es Lead cross-cultural teams effectively Work closely with customers and their broader RA teams while managing internal teams Collaborate with various departments for planning, preparation, publishing and quality control checks of submissions Effectively coordinate with cross-functional teams and customer teams to receive and track documents, finalize submission timelines, resolve handoff issues, identify gaps, and drive effective project execution Developing and maintaining up-to-date knowledge of established Health Authorities (US/CA/EU/UK and GCC) Support submissions in eCTD format Coordinate with the Team and maintain quality, productivity and timeline, Adhere to internal or customer process and standards Plan appropriate resources needed to support submission management and publishing activities which include short and long-term resource planning Be accountable for the management of the projects, meeting regularly with the project teams to identify and resolve issues and to assess quality and delivery effectiveness Provide on- the job training to follow train the trainer model for beginners/ fellow colleagues and provide QC feedback for continuous improvements Initiate, author and/or collaborate on SOP’s, work instructions and Workflows for the regulatory operations function Provide feedback to clients on the SOP’s/ process improvements to achieve quick turnaround deliverables and immediate effort efficiencies to client Plans, coordinates and prepares responses to various requests such as requests for proposals (RFPs), requests for information (RFIs) and requests for quotes (RFQs) Participate in BD calls as a SME and provide inputs for the customer requirements Sound understanding of Regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business *Candidate will support top Pharma* Qualification Graduate/Post-Graduate with a life sciences degree (Preferably Pharmacy or any life sciences domains or equivalent) Experience and Skills 15 to 20 years’ experience working in regulatory publishing process and strong analytical skills Significant 'Hands on' experience in creation of submission output for eCTD submissions Proven ability to successfully understand the submission and agency requirements Effective coordination with cross functional teams in receiving, tracking the documents, addressing the gaps for effective project execution Executed Initial IND/ NDA/ MAA/ BLA projects as well LCM submissions with tight turnaround time and achieved with first time right time submissions with zero HA rejection Knowedge on all the submission types including promotional submissions/product launch activities Proven strength in logical, analytical and writing ability essential Managed a publishing team and be the POC for client Effective leadership, mentoring and communication skills #J-18808-Ljbffr Navitas Life Sciences Pvt. Ltd.