• Career Opportunities: Regulatory Services Support Jobs in Gurgaon,India

  • PI Industries Ltd

Job Description:

Position Description

Business Division

Agri Input

Department

Product Evaluation & Registration

Location Gurgaon

Position Title Position Description

Regulatory Support Trials & Documentation

Level

E4 J2

Reporting to (Title)

Head, Product Evaluation and Registration

Position Purpose

The role holder is responsible for timely and accurate completion of all documentation activities for Product Evaluation and Registration The role is responsible for compilation of results of Product Evaluation (PE) trials in specified formats and preparing dossiers for registration as per regulatory requirements

Strategic Responsibilities

Provide reports on competitor activity, new molecules registered, market intelligence as directed by Head, PE & Registration

Operational Responsibilities



Financial Responsibilities

Ensure compilation of trial reports, in coordination with the Product Evaluation team, as per specified documentation guidelines and formats (for example, bio-efficacy, chemistry, toxicity, residue reports)
Communicate documentation and reporting requirements to the Product Evaluation team, to ensure standardization in reporting of research, trial and testing results (for example, data collection formats, reporting formats, supporting field data requirements, sample requirements, submission timelines)
Be updated of regulatory changes in documentation and reporting requirements, ensure internal dossiers and registration formats are updated appropriately, as per revised guidelines
Prepare dossiers for submission as per regulatory requirements, within specified timelines (for example, documentation under section 9(3) and 9(4), export registration, endorsement cases, import permits)
Ensure accuracy of dossier data compiled, highlight data deficiencies to the Manager, and ensure necessary corrective actions are implemented and incorporated in the dossier report (for example, repeating trials, revision of technical data, incorporating supporting documentation)
Ensure resolution of queries on product dossier deficiencies and clearance of the same, within specified timelines (for example, data related, formats related, technical queries)
Validate reports and submit findings to Product Evaluation team for eg toxicity and residue reports, bio-efficiency reports
Provide documentation support to the Regulatory Affairs function, for all New Product Registration activities, as required (for example, export registration, import permits, endorsement cases)
Support the Regulatory Affairs team, in resolution of documentation related queries from regulatory authorities (for example, Registration Committee)
Provide documentation support to the Head, PE and Registration, in any secondary research/ documentation as required and directed from time to time
Follow documentation / archiving / filing processes & procedures for all new product registrations, trials and research
Support the Head - PE and Registration in any secondary research / documentation required as directed from time to time
Respond to queries related to documentation raised during Audits (Internal / External Quality, Financial Audits)

People Responsibilities

Attend trainings on training needs identified or imparted by HR to enhance performance

Education Qualification

BSc(Agri)/MSc(Agri)

Work Experience

3 to 5 years experience in technical documentation related to agro products registration

Industry to be Hired from

Agro chemicals

Functional Competencies

Good Knowledge of compliance, documentation and regulatory requirements for Product Evaluation and Registration (including statutory guidelines, documentation requirements, dossier submission and registration procedures)
Good Proficiency in MS-Office / Designing Software & Tools

Interaction Complexity and Team Work

Interaction

Frequency

Purpose of Interaction

Internal

Head - PE and Registration, Product Evaluation, Regulatory Affairs,

As and when required

Compilation of research, trial and testing reports, documentation for internal committee approvals, product dossier preparations and submissions for registration, resolution of queries on dossier deficiencies, documentation support for other functions for registration activities

External

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Agriculture/Forestry/Fishing, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Drug Regulation
Salary : As per Industry Standards
Deadline : 14th Mar 2020

Key Skills:

Company Profile:

Company
PI Industries Ltdarfix

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