April 10, 2023 nitin nimbalkar
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.
- Education & Experience requirement – 2 Open Positions.
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.