Assistant Manager Regulatory Affairs

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: