Regulatory Affairs Officer

Asoj Soft Caps

3 - 8 years

2 - 4 Lacs

vadodara

Posted:7 hours ago| Platform:

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Skills Required

regulatory affairs dossier drug regulatory affairs compilation dossier preparation dossier compilation ms office actd ectd regulatory submissions ctd row market formulation active pharmaceutical ingredient dmf

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities

As a regulatory affairs officer:

ensure that a company's products comply with the regulations of the regions where they want to distribute them
keep up to date with national and international legislation, guidelines and customer practices
respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.
collect, collate and evaluate scientific data from a range of sources
develop and write clear arguments and explanations for new product licences and licence renewals
prepare submissions of licence variations and renewals to strict deadlines
monitor and set timelines for licence variations and renewal approvals
work with specialist computer software and resources
write clear, accessible product labels and patient information leaflets
plan and develop product trials and interpret trial data
advise scientists and manufacturers on regulatory requirements
provide strategic advice to senior management throughout the development of a new product
project manage teams of colleagues involved with the development of new products
oversee product trials and interpret trail data
undertake and manage regulatory inspections
review company practices and provide advice on changes to systems
liaise with, and make presentations to, regulatory authorities
negotiate with regulatory authorities for marketing authorisation
take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities

Preferred candidate profile

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