Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)

Grade G12A/G11B

Education B.Pharm / M. Pharm

Experience 4 to 6 years

Location R&D - Baroda

Job Description:

• Review all data and documents related to product registrations for various health authorities.

• Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

• Prepare responses to deficiency letters received from various agencies.

• Maintain life-cycle / post approval changes for drug product registration dossiers.

• Provide regulatory support to cross functional departments.

• Prepare and submit scientific advice to various health authorities.

• eCTD compilation, verification and submission through electronic gateway

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.