Regulatory Affairs Executive

6 days ago

Bangalore, 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 s hould 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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