Assistant Manager Regulatory Affairs

Hiring for A reputed pharma MNC

from 2 to 5 year(s) of Experience
Gurgaon
INR 4,00,000 - 5,50,000 PA.
Posted: 24 days agoOpenings: 1Job Applicants: 207Job Views: 532

Job Description


  • Designation – Assistant Manager
  • Qualifications: - B.Pharma/M.Pharma
  • Experience: - 2 to 4 years (Export & Import with multiple countries of Cosmetic & Pharma)
  • Gender – Female/Male
  • Should be open to travel
  • CTC – Upto 5.5 Lacs

Regulatory Affairs

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

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.

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.

Teleconferences with global affiliates to process and clarifications on documents for ease of applications to be submitted as CDSCO, New Delhi.


Preparation and submission of query response to DCGI (Drug Controller General of India) for cosmetic application.


Review and analysis of the ingredients and its concentration used in formulation to complies the BIS (Bureau of Indian Standardization).


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

Review and correction of art work/labels and carton as per rule 148 of Drug & Cosmetic Act, 1940.


Updating of all trackers pertaining to the various application and coordinating regularly with senior management in all aspects of the registration process.


Regulatory liasioning and follow up with CDSCO office for status of applications and for any new update regarding our registered products.


Successfully granted numerous of cosmetic import license.


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:

Adverse event reporting and govt. accreditation bodies coordination

Completing periodic safety update reports

Writing and review serious side effects

Identifies appropriate regulatory agency directions and makes case referrals

Carefully reviews and documents regulatory agency requests.

Prepares responses based on requests.

Prepares clear periodic reports.


Medico-marketing

Design and develop the training programs for sale team

Organize trainings of sales team on Quarterly and annually basis

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

Coordinate, observe and track learning progress of the sale team

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

Preparing medical presentation, monographs, launch presentation for new launch

Salary: INR 4,00,000 - 5,50,000 PA.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Legal, Regulatory, Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Full Time, Permanent

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy

Company Profile

CIEL HR Services Pvt Ltd

A client of CIEL dealing in skin care/derma and cosmetics

View Contact Details+

Contact Company:CIEL HR Services Pvt Ltd

Reference Id:2

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