Purpose
This position will be accountable for the regulatory filings in the US market, especially for
complex products, drug-device combinations, oncology and high potent products.
Position / JobTitle
Senior Manager
DepartmentRegulatory Affairs
Reporting To
Senior General Manager – Regulatory Affairs
LocationThane
Years of Exp
15-18 years
Dosage Form
Know-how of all dosage forms
Job Responsibilities / Deliverables
- Prepare regulatory strategies for US market.
- Compile, 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, especially for complex products, drug-device combinations, oncology and high potent products.
- Plan, review and submit pre-approval submissions including pre-IND, IND, pre- NDA, pre-ANDA, CGT requests and query responses.
- Plan all the regulatory workto meet the filing schedule.
- 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.
- Support operational excellence within Regulatory setup.
Qualifications & Pre-Requisites
- Proficiency in Regulatory Affairs and experience in complex products and drug device combination products.
- Knowledge of Pharmaceutical Development and Manufacturing.
- Excellent leadership, analytical, communication, planning, interpersonal skills and act as a solution provider.
- Experience working withUSFDA
Additional notes-Willneed to work in different shifts
