Sr. Executive Drug Regulatory affairs DRA
3 hours ago
Ensure that the company's products comply with the regulations of the regions where the company wants to distribute the products.
2.
Keep up to date with national and international legislation, guidelines, and customer practices.
3.
Respond to queries from medical bodies like the Medicines and Healthcare products Regulatory Agency (MHRA).
4.
Develop and write clear arguments and explanations for new product licences and licence renewals, and prepare submissions of licence variations and renewals to strict deadlines
5.
Monitor and set timelines for licence variations and renewal approvals.
6.
Write clear, accessible product labels and patient information leaflets
7.
Plan and develop product trials and interpret trial data
8.
Advise on regulatory requirements, provide strategic advice to senior management throughout the development of a new product
9.
Involved with the development of new products, oversee product trials, and interpret trail data
10.
Review company practices and provide advice on changes to systems
11.
liaise with, and make presentations to, regulatory authorities and negotiate with regulatory authorities for marketing authorisation
12.
Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
Job Type: Full-time
Pay: ₹22, ₹35,000.00 per month
Work Location: In person
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