Senior Regulatory Affairs Officer
1 Nos.
53790
Full Time
5.0 Year(s) To 7.0 Year(s)
3.00 LPA TO 5.00 LPA
Pharma / Biotech / Healthcare / Medical / R&D
Export/Import
B.Pharma - Pharmacy; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry
Job Description:
Job Description:
To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.
- 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.
Company Profile
companies are a leading manufacturer of finished pharmaceutical formulations based at Vadodara, Gujarat.Company boasts of wide portfolio of products ranging from General Tablets, Oral Liquids, Capsules, Beta-Lactum tablets, Dry powders, Injectables & Ointments being manufactured at its state of the art facility having WHO- GMP certified facility.
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