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
• Also manage day-to-day operations using project management and planning tools, create and maintain detailed project timelin
• 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

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* Candidate will support top Pharma*

Graduate/Post-Graduate with a life sciences degree (Preferably Pharmacy or any life sciences domains or equivalent)

• 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