Pharma Tips

Regulatory Affair Executive Client of India Pharma People

By: Pharma Tips | Views: 2318 | Date: 24-Apr-2011

• Good knowledge of Regulatory Requirements like ANVISA/MCC/EU/UK MHRA and ICH Guidelines• Well versed with eCTD/ACTD submissions• Good experience and knowledge about review of documents like Batch Manufacturing & Packing Records, Process Validation Protocols, COAs, Stability data etc. in a pharmaceutical company.

Summary

Experience:

1 - 4 Years

Location:

Mumbai

Compensation:

Best In Industry

Education:

UG - Any Graduate - Any Specialization,Graduation Not Required PG - Any PG Course - Any Specialization,Post Graduation Not Required

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

22 Apr

Desired Candidate Profile

• Good knowledge of Regulatory Requirements like ANVISA/MCC/EU/UK MHRA and ICH Guidelines

• Well versed with eCTD/ACTD submissions

• Good experience and knowledge about review of documents like Batch Manufacturing & Packing Records, Process Validation Protocols, COAs, Stability data etc. in a pharmaceutical company.

Job Description

• Knowledge of/Experience in Finished Formulation Product Registration Dossiers/Documents filling for Solid Dosage forms

• Creation and Compilation of International regulatory dossiers for Regulatory Agencies across countries like TGA/MCC/UK MHRA/ANVISA

• Preparation of Product Dossiers in multiple dosage forms like tablets, suppositories, oral suspensions etc

• Coordinating with concerned departments like Quality Assurance/Quality Control/Production to procure the documents for compilation of dossiers and meet the submission timelines.

• Extend complete technical support to the business team, by submitting the Registration Dossiers within the timelines to obtain international market clearances.

• Facilitate quick response to technical queries from various regulatory agencies

• Coordinate with International marketing authorization persons to manage and ensure compliance of regulations and on-time submissions

• Review of all technical documents for adequacy and accuracy before compilation/submission of dossiers

• Study the Regulatory Requirement and Prepare Strategy to enter new markets with the help of the business development team.

• Guide and Assist the R&D team with relevant information on various studies required for specific countries like ANVISA/TGA/MCC

• Conduct Quality Review of various documents like BA/BE Studies/Stability Studies

Keywords: Regulatory affair, Product registration, Registration Dossiers,Regulatory Agencies, Product dossiers,Technical Documentation,

Company Profile

A major Pharma Co.
Contact Details
Company Name:

Client of India Pharma People

Website:

Not Mentioned

Executive Name:

Mr Deepak Sanhotra

Address:

Not Mentioned

Email Address:

deepak@ipp.co.in

Telephone:

09325098694

Reference ID:

RA

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