Assistant Manager Regulatory Affairs

Designation – Assistant ManagerRegulatory Affairs1. Proactive planning for all regulatory submission as per business requirement & newrequisition received from the Spain.2. Compilation and review of registration application, online uploading of documents, hardcopy submission to Cosmetic section of CDSCO (Central Drug Standard ControlOrganisation), New Delhi.3. Drafting of all regulatory/administrative documents to get the registration certificate and noobjection 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 ofapplications to be submitted as CDSCO, New Delhi.5. Preparation and submission of query response to DCGI (Drug Controller General of India) forcosmetic application.6. Review and analysis of the ingredients and its concentration used in formulation to compliesthe BIS (Bureau of Indian Standardization).7. Notify to company regarding banned and restricted ingredients as per updated BISStandards.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 anynew 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) (Registerour company under FSSAI Division), drug claim products and medical devices.Pharmacovigilance:

Educational Details: Professional certificate

City: Gurgaon

State: Haryana

Postal Code: 122002

Recruiter: nidhi Chakhaiyar - +91 92657 23772

Qualifications: Professional certificate

Experience: 2-4 year

Salary:

Industry: Pharma & cosmetics

Openings: 1