Regulatory Affairs Associate

2 days ago

Mumbai Maharashtra, India Fusion Market Research Full time

_**Responsibilities**:_

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 the Medicines and 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
- 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
- oversee product trials and interpret trail data
- 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, Permanent, Fresher

Pay: ₹315,023.20 - ₹574,442.11 per year

**Benefits**:

- Health insurance
- Life insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Joining bonus
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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