Regulatory Affairs

4 weeks ago

Bengaluru, India Surgeway Biosciences Private Limited Full time

JOB TITLE :
Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)

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 contributor. 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 (Philippines, Nigeria, Zambia, Ethiopia, Kenya, Myanmar, Cambodia,)


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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