Unichem Laboratories Limited Looking For Officer / Senior Officer- Regulatory Affairs – EU at Mumbai, Maharashtra, Full Time

Position Overview:

• Handling assigned activities in the regulatory department.

Experience:

• 5-8 years

Qualification:

• B. Pharm, M.Pharm preferred.

Responsibilities:

• Compilation of ANDA submissions in accordance with the latest guidances assuring technical congruency and regulatory compliance.
• Identify the required documentation for EU regulatory submissions and compilation of MAA submissions for EU accordance with project timelines.
• Review and identify content, and documents, related to dossiers compilation or query response.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Providing responses to queries and issues received from regulatory authorities proactively.
• Compilation and submission of CBE-0, CBE -30, labelling supplements and annual reports and variation applications for EU.
• Generation and submission of SPL for drug listing.

Desired Skills:

• Must have hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
• Should have handled original MAA submission for EU.
• Good technical knowledge, review skills and understanding of regulatory submissions.
• Strong knowledge of CTD /eCTD requirements for submission of dossiers.
• Ability to try new approaches when faced with challenges.
• Should have good analytical and learning attitude.
• Good communication (written and oral) and inter-personal skills.