Assistant Manager Regulatory Affairs

Job description

What you will do

• Designation – Assistant Manager
• Regulatory Affairs
• 1. Proactive planning for all regulatory submission as per business requirement & new
• requisition received from the Spain.
• 2. Compilation and review of registration application, online uploading of documents, hard
• copy submission to Cosmetic section of CDSCO (Central Drug Standard Control
• Organisation), New Delhi.
• 3. Drafting of all regulatory/administrative documents to get the registration certificate and no
• objection certificate for various application for cosmetics, device and query response as well.
• 4. Teleconferences with global affiliates to process and clarifications on documents for ease of
• applications to be submitted as CDSCO, New Delhi.
• 5. Preparation and submission of query response to DCGI (Drug Controller General of India) for
• cosmetic application.
• 6. Review and analysis of the ingredients and its concentration used in formulation to complies
• the BIS (Bureau of Indian Standardization).
• 7. Notify to company regarding banned and restricted ingredients as per updated BIS
• Standards.
• 8. Review and correction of art work/labels and carton as per rule 148 of Drug & Cosmetic Act,
• 1940.
• 9. Updating of all trackers pertaining to the various application (Sesderma and Mediderma)
• and coordinating regularly with senior management in all aspects of the registration process.
• 10. Regulatory liasioning and follow up with CDSCO office for status of applications and for any
• new update regarding our registered products.
• 11. Successfully granted numerous of cosmetic import license.
• 12. Work on other guidelines i.e. FSSAI (Food Safety and Standard Authority of India) (Register
• our company under FSSAI Division), drug claim products and medical devices.
• Pharmacovigilance:

Job details

How to apply

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