Regulatory Affairs Executive

Lyrus

4 years

0 Lacs

bengaluru karnataka india

Posted:1 month ago| Platform:

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Skills Required

gcc software communication cdp stability reports sequence database tracking

Work Mode

On-site

Job Type

Full Time

Job Description

Job position

Sr. Officer / Executive

Educational qualification

Graduation/post-graduation in Pharma, science or any life science

Function/department

Regulatory affairs

Expected year of experience

4+ years

Mandatory technical skill and experience

Atleast 4 years of experience in Regulatory Affairs
Hands on dossier handling (M1 to M5) in Europe & Australia region for OSD
Dossier preparation in other regions like, US, South Africa, GCC and ROW is considered as add on experience
e-CTD software management

Other skills

Good verbal and written communication skills
Should be a team player
Must be able to meet deadline with a positive attitude and atmosphere

Key Responsibilities

Coordinate with the cross functional team members for the documents
Hands on review of technical documents like specifications, AMV, CDP, stability reports
Prepare and review product labels for Europe and other markets
Preparation and compilation of IND dossier for submission to EU, TGA and semi regulated market.
Preparation of variation sequence
Respond to the queries within assigned timelines.
Maintain regulatory database and documentation.
Develop and manage regulatory tracking systems to monitor submission timelines and approvals.

Apply online at https://bit.ly/LyrusRA

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