Regulatory Affairs Executive

2 weeks ago


Bengaluru, India SurgeWay Biosciences Full time

JOB TITLE : Regulatory Affairs Executive - ROW markets


WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?


As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration, performance enhancement, as well as how to be an effective manager. At Surgeway Biosciences, we offer much more than just a job. We strive to give you a Promising and Bright Career path.


PRIMARY GOAL FOR THE ROLE


Complete technical know how about dossiers, and dossier compilation (for ROW markets) - and generating new dossiers and reviewing existing dossiers, in a timely and accurate manner.


Roles & Responsibilities:


> To prepare and compile a registration dossier as per the CTD / ACTD / Country specific guidelines -

specifically for ROW markets (Myanmar, Cambodia, Philippines, Nigeria, Zambia, Ethiopia, Kenya)


> Must be aware of the contents of a Dossier, and should be knowledgeable about all the documents attached in dossiers


> To prepare, review /check artwork, pack insert, SmPC, etc.


> To verify all technical documents and information received from various departments at the manufacturing site.


> To verify specification of excipients, active, finished product, and packaging material

and all required documents.


> Must be aware of Biosimilars/Drug products submission procedure for ROW countries


> Must be aware of the ICH guidelines and the updates on the same

> To reply to any queries raised by respective regulatory authorities, in a timely manner.


> Maintains the highest level of submission standards.


Requirements:


> Prefer professionals with experience in Dossier preparation and Submission-

for ROW markets (Especially South East Asia and East Africa)


> Two to Three years’ experience in Pharma Regulatory Affairs will be preferred


> Immediate Joining or 15-day's Notice Period is preferred.


Candidate Profile:


> M.Pharm candidate with 2-3 years of experience in the RA department (for ROW countries)


> Good communication skills in English


> Ability to grasp new concepts quickly


> Must have a systematic approach to solving problems.


> Must be able to understand the techniques and processes used


> Excellent PC skills, should be proficient with the usage of the internet as a tool to find

necessary and useful information.


> Must be organized- timely, and with information/data.



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