Executive Regulatory Affairs
2 weeks ago
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
**Education**:
- Bachelor's (required)
**Location**:
- Kalher, Thane, Maharashtra (required)
Shift availability:
- Day Shift (required)
Work Location: In person
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