EXECUTIVE DRUG REGULATORY AFFAIRS Full-time Job

Job Responsibility

· Preparation and submission of dossiers as per countries assigned.

· To handle inquiries from Regulatory Authorities related to company and product

registration.

· Submission of Registration Dossiers in EU, Semi-Regulatory and Emerging market.

· FDA related work- Application of COPP, Legalization of Documents through different

· embassies.

· Co-ordinate with departments, Manufacturing, Product Development, QA/QC, R&D,

· Legal, Purchase etc. to ensure availability of documents and samples for submission.

· To check, review and prepare Artworks, Labels, and Pack-inserts in co-ordination with

· Art department and printers for domestic and international markets.

· To verify for completes of documents such as Process Validation, Product development

· records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers.

· Response of queries and other requirements as required by respective regulatory

· authorities in a stipulated timeframe.

· To prepare CTD & ACTD dossier. (Southeast Asia, Middle East countries)