Regulatory Affairs Associate

1 day ago

Kalher Thane Maharashtra, India LAPAROMED PVT LTD Full time

As a regulatory affairs officer, you'll need to:

- 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 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.
- 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.

Pay: From ₹15,000.00 per month

Schedule:

- Day shift
- Morning shift

Work Location: In person

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