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Urgent Opening for Regulatory Affair Jobs

By: Pharma Jobs | Views: 3382 | Date: 01-Nov-2012

Quest Consultants, an Executive Search & HR Consultancy is a young emerging organization established by HR professionals with the objective of providing comprehensive staffing & Manpower solutions to the organizations. We believe in understanding the client"s business, so as to proactively align the HR process with the business needs of our clients. We believe in providing a "ONE STOP" solution for all the HR related activities.

Urgent Opening for Regulatory Affair Jobs

 

Experience required for the Job: 0 - 10 years
Annual Salary of the Job: 1.0 - 2.0 Lacs
Job Location: Ahmednagar, Aurangabad, Jalgaon, Kolhapur, Mumbai, Mumbai Suburbs, Nagpur, Nasik, Navi Mumbai, Pune, Solapur, Maharashtra - Other


Dear Candidate,

This is regarding your profile on the job portal & it is matching with our requirement for the position of 'Officer DRA for ANDA market ' for leading Pharma at kandivli

About Us:

Quest Consultants, an Executive Search & HR Consultancy is a young emerging organization established by HR professionals with the objective of providing comprehensive staffing & Manpower solutions to the organizations.

We believe in understanding the client"s business, so as to proactively align the HR process with the business needs of our clients. We believe in providing a "ONE STOP" solution for all the HR related activities.

Our client:

Our Clinet is a specialty pharmaceutical company engaged in the development, manufacture and commercialization of pharmaceutical products. We employ over 3,200 people worldwide and our products are sold in over 30 countries. Our Clinet operates with 5 state-of-the art manufacturing facilities that produce high quality pharmaceutical products. We focus on commercializing unique generic products and pioneering synergistic combination products in the therapeutic areas of anti- malarial, cardiology, dermatology, gastroenterology, musculoskeletal, ophthalmology and respiratory

Position : Officer DRA

Location : kandivli


Job Discription

1)Preparation of registration dossiers for Rest Of the World market.
2)Query evaluations and further additional data requirement action plan and to respond the same upon regulatory review as per the committed timelines.
3)Co-ordination with core team (QA/RND/Marketing etc.) during the dossier assessment queries.
4)Handling all queries and to respond, in a timely manner in consultation with responsible personnel of manufacturing, R&D, QC & QA and to compile response documents and submit them.
5)To evaluate and submit the post approval changes in the registration if required, upon regulatory evaluation as per the variation regulation of respective country and as directed by the Head of the department.
6)Updating the Group leaders on the status of respective countries on weekly basis
7)To communicate with all appropriatee Quality Assurance (QA) personnel, internal or external to company.
8)Updating team members on the latest regulations and guidelines of the countries.
9)Regular follow up and update on regulatory functional and dossier submission strategy as directed by Head of the department.

Send Your resume below E mail Id

Quest Consultants:

purvi@evokehr.com

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