Immediate opening in Regulatory Affairs

from 4 to 8 year(s) of Experience
₹ Not Disclosed by Recruiter

Job Description

Dear All,

Greeting from Hetero Biopharma.

We have an opening for Regulatory Affairs Position

Department: Regulatory Affairs

Designation: Sr.Executive /Asst.Manager

Experience: 4 Yrs. to 8 Yrs.

Job Location: Jadcherla(Telangana)


Job Responsibilities

1. To verify the country specific guidelines, evaluate & submit the dossiers as per the client/MOH requirements.
2. To prepare the dossiers (eCTD, CTD & country specific format) that review, organization for AFRICAN, CIS, LATAM and MENA region countries.
3. Receipt and submission of responses to the queries of dossier of data packages submitted to AFRICAN, CIS, LATAM and MENA countries.
4. To co-ordinate with cross functional teams to initiate the new studies for suffice the query response & dossier requirement towards country specific requirements for product registration.
5. To prepare & submission of post approval changes (PAC) in accordance with country specific variation guidelines & get the approvals.
6. Keeping abreast with updating of country specific regulations and guidance.
7. To co-ordinate with CFTs for preparation of Master Artworks.

Interested Candidates share profile to edukondalu.m@heterodrugs.com


Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Other

Role Category:Other

Employment Type:Full Time, Permanent

Education-

UG:

PG:Any Postgraduate in Any Specialization

Doctorate:

Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
View Contact Details+

Contact Company:Hetero Drugs Limited

Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India

Copyright © 2017 Hetero. All rights reserved.
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