Alkem Labs Pharmaceutical Chemistry Jobs – Apply Online
Executive/Sr. Executive – Regulatory
Mumbai, Maharashtra, India
About the job
About Alkem
Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations, and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top ten pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.
Role & responsibilities:
Responsible for Dossier compilation:
- To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa, Mexico and Brazil filing and Regulatory knowledge of Guidelines viz, ICH, FDA PICs etc.
- To review accuracy of executed data before submission – Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
- To review of documents for adequacy and accuracy.
- To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
- To arrange the samples as per country requirements.
Responsible for Tender compilation:
To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings.
Ensure timely delivery of regulatory query:
- To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
- To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.
Other activities:
- To maintain Data Bank for Commercial activity.
- To work with quality standards and adherence to system.
Compliance (Audits / Audit Readiness):
Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
Qualification: M.Pharm (Preferable Pharmaceutical or Chemistry)
Experience: 2-4 years and candidates should have at least experience of handling one of these countries (South Africa / Brazil / Chile / China/ Malaysia / South Korea).
Keywords: Alkem Laboratories, Pharma Jobs, Executive Regulatory, Mumbai, Maharashtra, India, Regulatory Compliance, Tender Compilation, Regulatory Query, Quality Standards, Audit Readiness, M.Pharm, Pharmaceutical, Chemistry. Alkem Labs Pharmaceutical Chemistry Jobs – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.