Regulatory Affairs
6 days ago
**Description**:
- They must have excellent organizational, analytical, project management, and communication skills.
- They work frequently with other employees and team members to coordinate complex activities, often with competing priorities.
- Most regulatory affairs positions are full time.
- Regulatory Responsibility means a duty or responsibility, assigned to an individual by management.
- Regulatory compliance is when a business follows state, federal, and international laws and regulations relevant to its operations, Regulatory compliance involves following external legal mandates set forth by state, federal, or international government.
- 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.
- liaise with, and make presentations to, regulatory authorities.
- negotiate with regulatory authorities for marketing authorization.
**Salary**: ₹12,000.00 - ₹20,000.00 per month
Ability to commute/relocate:
- Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
**Speak with the employer**
+91 9327901434
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