Kimia Biosciences Ltd™, engaged in manufacturing of bulk drugs addressing to various high potential therapeutic segments and has envisaged high growth plans through infrastructure creation and CMS is looking to hire a Regulatory Affairs Executive for their Delhi Office.
Roles and Responsibility: –
Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation
To define Regulatory strategy for filing of DMF/ANDA based on specific requirements of the various agencies ensuring compliance with regulations set by the Regulatory Agency
To File DMF/ANDA with Regulatory agencies
To monitor and complete any deficiency in the regulatory filing or any query from the agency
Response to any regulatory agency
Response to any customer taking data from QA or any other concerned department planning, undertaking and overseeing product trials and regulatory inspections keeping up to date with changes in regulatory legislation and guidelines offering advice about company policies, practices and systems obtaining marketing permission
Outlining requirements for labeling, storage and packaging
Liaising and negotiating with regulatory authorities providing advice about regulations to manufacturers/scientists writing comprehensible, user-friendly, clear product information leaflets and labels ensuring that quality standards are met and submissions meet strict deadlines
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About the Company:
Kimia Biosciences Ltd™ is engaged in manufacturing of bulk drugs addressing to various high potential therapeutic segments and has envisaged high growth plans through infrastructure creation and CMS. Company has earmarked significant investment for this over next two years to be one of the major players in the Indian market. Moving forward towards vertical integration Kimia has plans to set up its own FFF facilities for Life Style segments with international regulatory standards to be able to not only launch itself in ROW but advance markets as well in future times.
We envision becoming the most admired pharmaceutical company in India for clean and ethical business and marketing practices and establishing us in both APIs and FDFs globally.
Company believes in maintaining the highest level of integrity, transparency and ethics. We embrace community values and culture and focus on delivering world class solutions and affordable costs.