Regulatory Affairs Executive

2 weeks ago


Anand, India Infinium Healthcare Pvt. Ltd Full time

**Qualification**:

- M.Pharm/MSc**

**Exp:

- 1 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 licences 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
- Rotational shift

Ability to Relocate:

- Anand, Gujarat: Relocate before starting work (required)

Work Location: In person



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