Executive Regulatory Affairs - Navi Mumbai, Maharashtra, India - M/S. PRISM LIFE SCIENCES LIMITED

M/S. PRISM LIFE SCIENCES LIMITED

Verified Company

Navi Mumbai, Maharashtra, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Role & responsibilities
- 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 Healthcare products Regulatory Agency (MHRA)
- 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.

Salary:
₹20, ₹30,479.84 per month

Benefits: