04/08 Rajesh Kumar
Head Job Consultant at Project X Placements

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Assistant Manager - Regulatory Affairs - Hospital (2-5 yrs)

Sector 26, Gurgaon Job Code: 11011

Job Description:

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 compliesthe 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:

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 trainings 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

Job Details:

Location: Sector 26, Gurgaon

Shift Timings: 10:00 am - 7:00 pm (day shift)

Weekly Working Days: 6 Days

Off Days: SUN

Note: Monday to Saturday (2nd and 4th Saturday off)

Salary: - 3.0 Lac to - 5.0 Lac Annually

Selection Criteria:

Education:

- Bachelor of Pharmacy (B.Pharma.)/ Master of Pharmacy (M.Pharma.) mandatory

Experience:

- 2 yrs to 5 yrs of experience as Sales / Business Development or Medical Representative in Healthcare / Medical or Pharmaceutical mandatory

- Excellent Communication Should be open to travel Mandate experience in Export & Import with multiple countries of Cosmetic & Pharma.

Documents:

- Cheque Book / Pass Book

- Joining and Relieving Letters

- Marksheets and Degree

- Salary slip

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