Senior General Manager

This position will lead and be accountable for the pre-approval regulatory efforts in the US

Director – Regulatory Affairs & IP

20+ years

Know-how of all dosageforms

• Prepare Regulatory Strategies for US market.
• Review and submit quality dossiers in the US market in line with regulatory strategy and expectations including Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs) or 505(b)(2) applications.
• Plan and manage all pre-approval submissions including pre-IND, IND, pre-NDA, pre-ANDA, CGT requests and query responses.
• Manage various filings including submission of meeting requests, teleconference requests or controlled correspondence.
• Plan all the regulatory workto meet the filing schedule.
• Interact with the regulatory agencies and manage meetings with them as necessary.
• Coordinate with various stakeholders including Development Centers, Manufacturing Units, Quality Units, Supply Chain for needful documentation for timely and quality filings.
• Provide necessary regulatory clearances and assessments during the product development process including inactive ingredient clearances, biowaiver and size and shape clearances.
• Address any queries from the stakeholders regarding regulatory filings.
• Advise and guidethe team on regulatory matters.
• Support organizational initiatives and manage the team to meet thedeliverables.
• Ensure business growthand operational excellence within Regulatory Set up.

• Proficiency in Regulatory Affairs.
• Knowledge of Pharmaceutical Development and Manufacturing.
• Excellent leadership, analytical, communication, planning, interpersonal skills and act as a solution provider.
• Experience workingwith USFDA
• Manage 100+ submissions annually including original filings and queryresponses.