SurgeWay Biosciences | Regulatory Affairs Executive | bangalore
3 days ago
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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bangalore, India SurgeWay Biosciences Full timeJOB 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...
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bangalore, India SurgeWay Biosciences Full timeJOB TITLE : Regulatory Affairs Executive - ROW marketsWHY 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,...
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bangalore, India SurgeWay Biosciences Full timeJOB TITLE : Regulatory Affairs Executive - ROW marketsWHY 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,...
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Bangalore, India SurgeWay Biosciences Full timeJOB 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...
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