Regulatory Affairs Executive
2 weeks ago
INFINIUM PHARMACHEM LIMITED is an NSE Listed, well known Pharmaceutical Intermediates& APIs manufacturing company since 2003.
**Post : Regulatory Affairs Executive**
**Qualification:
- M.Pharm/MSc**
**Exp:
- 0 to 3 Years**
- 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 licenses and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- 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 authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
**Location**:
- V.V Nagar,Anand, Gujarat
Schedule:
- Day shift
**Location**:
- Anand, Gujarat (required)
Work Location: In person
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