Job Description:

PurposeThis position will lead and be accountable for the pre-approval regulatory efforts in the US
market.
Position / JobTitleSenior General Manager/General ManagerDepartmentRegulatory AffairsReporting ToDirector – Regulatory Affairs & IP
LocationThaneYears of Exp20+ years
Dosage FormKnow-how of all dosageforms
Job Responsibilities / Deliverables
Prepare Regulatory Strategies for US market.
Review and submit quality dossiers in the US market in line with regulatory strategy and expectations including Abbreviated Current Drug Applications (ANDAs), Current 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.

Qualifications & Pre-Requisites
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 qu

📌 Senior General Manager Thane (India)
🏢 Rubicon Research
📍 India