Senior Regulatory Affairs Officer

1 month ago


vadodara, India Paradise Placement Consultancy Full time

Job Description:

Job Description:

To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials

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 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 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.

Key Skills :

Regulatory Compliance Marketing Authorisation

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