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Regulatory Affairs Officer
2 weeks ago
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.
**Job Types**: Full-time, Fresher
**Salary**: ₹189,515.34 - ₹953,633.29 per year
**Benefits**:
- Cell phone reimbursement
- Health insurance
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Performance bonus
- Shift allowance
Ability to commute/relocate:
- Madurai, Tamil Nadu: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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