Unichem Officer / Senior Officer- Regulatory Affairs – EU
About the Company:
Unichem Laboratories Limited is a pharmaceutical company based in Mumbai, Maharashtra, India. We are dedicated to providing high-quality healthcare products and services to improve the well-being of people worldwide.
Handling assigned activities in the regulatory department.
Experience: 5-8 years
Qualification: B. Pharm, M.Pharm preferred.
- 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.
- 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.
Keywords: Unichem Officer, Senior Officer, Regulatory Affairs, EU, pharmaceutical, healthcare products, Mumbai, Maharashtra, India