Executive Regulatory Affairs

4 days ago

Vatva Gidc Ahmedabad Gujarat, India Halewood Laboratories Pvt Ltd Full time

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.
Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
obtaining marketing permission
outlining requirements for labelling, storage and packaging

**Job Types**: Full-time, Regular / Permanent

**Salary**: From ₹15,000.00 per month

**Benefits**:

- Health insurance
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Overtime pay
- Yearly bonus

**Experience**:

- total work: 2 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX

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