Regulatory Affairs Executive

Duties and Responsibilities:

• To review and prepare the dossiers in CTD/ACTD and specific formats per the country's guidelines.

• Minimum 5 years of experience preparing the registration dossiers for international markets.

• Experienced in coordinating and collecting dossiers, technical documents, samples, etc., from third-party manufacturers for product registrations.

• Experienced in preparing and checking the product label artworks, handling the FDA licenses / COPP applications, etc.

• Responding to queries from various MOHs in the stipulated time.

• To review the technical documents for preparing the dossier.

• Review the pack artwork and get approval for it from plants as well as from clients.

• Check the availability of the documents and evaluate them at different plants.

• To have a good knowledge of CTD & ACTD formats & well versed with ICH Guidelines

• To conduct reference study searches in libraries / Internet to accumulate comparative technical data on various formulations.

• To check the compliance status of the Quality Systems followed at the manufacturing site in line with the submitted dossiers.

• To evaluate and comment on the requirements of BE/Clinical Studies.

Skills and Qualifications:

• B-Pharma/M-Pharma Candidates can apply

• Preferably 5 to 10 years of experience in a DRA Department

• Experience with ACTD/CTD Dossiers.

• Exposure to Drug Regulatory Affairs.

• Good Knowledge of ICH guidelines.

• Technically Comprehensive.

• Fine Analytical Skills and Systematic approach.

• Proactive approach to problem-solving.

• Good computation Skills.

• Detail Oriented

• Logical Interpretation of Data.

• Multi-tasking ability.

• Fluent in English (Speaking, writing, reading, and understanding)

• Computer Skills (Ms. Excel, Ms. Word, Internet, Email)

If interested, please share your updated CV with the following details:

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