Associate - Regulatory Affairs at Genedrift

• 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.

Experience (Yrs)

• 3

Qualifications

• Masters in Pharmacy (M. Pharm)
• Bachelor of Pharmacy (B.Pharm)