Lead Regulatory teams to perform compliance audit of the dossiers and identifying non-compliances. Tracking of non-compliance till closure. Reviewing the audit report and ensure all NC is closed appropriately.
Managed the Global Regulatory Affairs team filing for all Regulated countries, handling multinational environment across multiple regulatory jurisdictions.
To assess the QMS documents and its impact on the regulatory filings Well versed with the latest US REQUIREMENT and guidelines for oral solids and injectable products Should have experience in handling a team of minimum 8 people Should be good in communication and leadership quality Should be able to communicate effectively within the group and with external customers Should have a good skill of problem solving.
To Involve in authorities Inspections like FDA, MHRA, MCC and TGA inspections for solid oral and Injectable facilities.