Dhananjay Dahale

About Dhananjay Dahale

Regulatory Affairs professional with over Twenty years of experience in the field of Drug…

Experience

1. Deputy General Manager Global Regulatory Affairs

   Apotex India

   Jul 2017 — Present · Mumbai, IN

   Accountable to lead and drive performance of Global Regulatory Affairs (GRA) team based in Mumbai, India. • Responsible to report the status & progress of regulatory activities to Global Regulatory Affairs Leadership team in Canada.• Define, develop and execute operational plan for the department with continuous improvement mindset, committed to excellence, whilst aligned to functional objectives.• Responsible for all GRA business processes, personnel and performance updates.• Develop & timely update processes for various regulatory activities handled by team.• Ensure timely submission of new registration applications to various authorities as per yearly plan.• Manage post-approval submissions for US, Canada, EU, AUS-NZ, GCC and rest of world markets. Manage regulatory impact assessment for change control.• Tracking of prior-approval submissions and deficiency/query response submissions.• Timely submission of health authority query responses, US Annual Reports, PADERs.• Manage labeling activities for US & Canada market.• Manage Regulatory eCTD Publishing team’s activity for various regions.• Collaborate & liaise with the stakeholders/customers globally to ensure seamless regulatory submissions and to avoid supply interruption.• Initiate and implement department-driven projects to bring continuous improvement in regulatory submission quality & timelines.• Timely monitor team’s capacity, productivity, utilization and manage resource planning.• Ensure team adheres to established regulatory compliance requirements and company policies & procedures.• Focus on talent management through talent recruitment, training/on-boarding, career progression and talent retention. Manage performance management and encourage high performance culture. • Team building & employee engagement activities to create a positive team environment.• Ensure adherence to team’s yearly budget.

Education

• Narsee Monjee Institute of Management Studies

  MBA

  2007 — 2011

Skills

• Vaccines
• Indian Dcg(I) Regulations
• Gcp
• Pharmaceutics
• Ctd
• Regulations
• Eu
• Formulation
• Generic Programming
• European Union
• Regulatory Submissions
• Clinical Trials
• Regulatory Projects
• Pharmaceuticals
• Regulatory Requirements
• Strategy
• Cmc
• Regulatory Affairs
• Compliance Assessment
• Eu Post-Licensing Activities
• Quality Assurance
• Pharmaceutical Industry