04/08 Tejasvini Pise
Corporate Acquisition Head at SuccessR HR Tech Pvt Ltd

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Regulatory Affairs Specialist - Hospital (2-5 yrs)

Gurgaon/Gurugram Job Code: 11015

Should have good knowledge and experience of BIS (Bureau of Indian Standardization).

Regulatory Affairs:

1. Proactive planning for all regulatory submission as per business requirement & new requisition received from Spain.

2. Compilation and review of the registration application, online uploading of documents, hard copy submission to Cosmetic section of CDSCO (Central Drug Standard ControlOrganization), New Delhi.

3. Drafting of all regulatory/administrative documents to get the registration certificate and no objection certificate for various applications 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 their concentration used in formulation to complies the BIS (Bureau of Indian Standardization).

7. Notify to the company regarding banned and restricted ingredients as per updated BIS Standards.

8. Review and correction of artwork/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 the status of applications and for any new update regarding our registered products.

11. Successfully granted numerous cosmetic import licenses.

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:

1. Adverse event reporting and govt. accreditation bodies coordination

2. Completing periodic safety update reports

3. Writing and review serious side effects

4. Identifies appropriate regulatory agency directions and makes case referrals

5. Carefully reviews and documents regulatory agency requests.

6. Prepares responses based on requests.

7. Prepares clear periodic reports.

Medico-marketing :

1. Design and develop the training programs for sale team

2. Organize training of sales team on Quarterly and annually basis

3. Conduct product demonstration/training's / workshops at their respective zone

4. Coordinate, observe and track learning progress of the sale team

5. Managing Stall Design, Product promotion, and related activities during Trade Shows and conferences

6. Preparing medical presentation, monographs, launch presentation for new launch

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