Purpose
This position will lead and be accountable for the pre-approval regulatory efforts in the US
market.
Position / JobTitleSenior General Manager/General Manager
DepartmentRegulatory Affairs
Reporting To
Director – Regulatory Affairs & IP
LocationThane
Years of Exp
20+ years
Dosage Form
Know-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 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.
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 queryresponses.
Additional notes-Willneed to work in different shifts
