Regulatory Affairs Officer/ Executive

Roles & Responsibilities for Regulatory Affairs Officer/Executive : –

Registration of products and manufacturing site with the regulatory authorities of various countries.
Understanding, Searching, Preparation, compilation and submission of Registration/ Site Registration documents for different countries
Understanding, Searching, Preparation, compilation and submission of Dossiers, Technical Files & CTDs/ACTDs/e:CTDs documents for different countries.
Interacting and conducting meetings with regulatory POCs from the distributors of the exporting countries inline to ensure regulatory requirements and compliance.
Identifying the guidelines and keeping up to date/record with the global regulatory requirements.
Coordinating with cross-functional teams for the regulatory activities.
Ensuring timely completion of regulatory activities and submission of regulatory documents.
Country wise/Client wise maintenance of all regulatory record
Any suitable activity assigned by Reporting Manager, CEO & Management.

1 No with MSc (Inorganic chemistry) and 1 No with M Pharm.

Fresher or preferably with 1 years of industrial experience in pharma field with Regulatory or quality function.