Genedrift is a leading consultancy and solutions provider for compliance and risk services for the Life Science industry, for Regulatory Affairs and Pharmacovigilance
We’ve been making the 'to-market' process faster and smarter, covering Drugs, Medical Devices, Cosmetics and Food Supplements. With operations across APAC, CIS, EU and North America, we c...
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Review of labels following local HA guidelines and advise customers on the best compliance practices.
Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA.
Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records.
Assist in the preparation of high-quality dossiers and thereon submission to HA.
Adequacy Review and Gap Analysis of Technical Documentation for the CTD dossier.
Closure of comments with internal teams, delivery owner and client team’s & review of additional incoming data.
Proper record keeping, complying with internal and client SOPs, while ensuring data security compliance.
Collaborate with internal teams, delivery owner and external clients for various functional/transition activities, including translation of documents, before and post submission to HA.
Prepare customized reports, to suit the client's objectives. Provide regulatory intel, knowledge, and market knowledge to ensure the success of the client’s application.
Supporting and enabling effective and efficient communication internally and externally to ensure operational excellence and client satisfaction.
Ensure the upkeep and safe custody of all original documents and records. Ensure compliance with QMS practices, while keeping all SOPs updated.
Stay updated and continuously update internal documentation in line with the guidelines of the HA.
Act as a Pharmacist-on-record/ Superintendent Pharmacist/ Director Pharmacist.
Candidate Profile
Should be a pharmacist, with a valid pharmacist license, and should be able to maintain this throughout.
Strong project management skills
Excellent interpersonal skills including problem solving, oral and written communication with effective presentation skills. Excellent computer skills and comfortable with online office applications.
Excellent knowledge of emerging markets and a keen eye to learn
Flexible, Adaptive, Ability to work under pressure, work with a focus on delivery, and provide quality outputs within tight timelines.
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