Regulatory Affairs Executive

Expectations

• Knowledge of various country specific regulatory requirements.

• Knowledge about dossier preparation for different countries.

• Identification & Rectification of errors in documents received for compilation of dossier.

• Respond to the queries of Regulatory Authorities and customers on time and effectively.

• Literature search and compilation of Pharmacological data of drugs for dossiers.

• Reviewing of artworks. Responsible for Checking of product Inserts for the product and follow up with different department for approval and finalizing it.

• Review of Specification (SPC) and Standard Analytical Procedure (SAP)

• Review of Validation/Verification protocols and reports for analytical procedures like Identification, Assay, Dissolution and Impurities for Finished products.

• Knowledge about basic calculation related to analytical method for finished product and API and about all type of physical parameter in different formulation.

• Review of analytical documents received from Plant.

• Good communication skills both written and verbal.

• Coordinate with R&D, Quality Assurance, Quality Control, Mfg. Locations, as well as interface with other departments to collect the complete set of documents.

• To prepare dossiers and all legal documents required for commercialization

Qualification Requirements

Education: M. Pharma, B. Pharma, M. Sc., B. Sc., Diploma in Regulatory Affairs

Experience: Min. 2 years

Candidate should be proficient in English reading and writing