Regulatory Chemist 7-12 Yr Exp – Regulatory Affairs Director Job Mumbai

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Job Description :

Reports To:
Origin Consultants Pvt Ltd an Executive Search Services Company has been retained by Highly Profitable Agrochemicals & Crop Protection Chemicals Export House to identify Regulatory Chemist to be based at Mumbai

Job Description

As a Regulatory Chemist your responsibilities include the following

  • Coordinate all aspects of testing projects with 3rd party laboratories including assessment of new data to meet regulatory reporting obligations
  • Conduct product chemistry and test material characterization studies that fully meet world-wide regulatory requirements to facilitate registration.
  • Ensure regulatory submission meet Good Laboratory Procedure requirements including method development and validation, GLP test and reference material characterization and conduct of GLP product chemistry studies
  • Support the registrations by providing priority analysis, methodology and expertise to EPA & investigating complaints
  • Summarize, analyze & interpret test results in preparation for submission to regulatory agencies.
  • Interface with worldwide regulatory agencies on technical issues, develop and present responses to their questions and requests, create documentation & maintain sample, records as per GLP / FDA / EPA / OECD regulation
  • Manage and coordinate multiple projects and chemistries with a project-based focus rather than research focus
  • Remain abreast of changes in global testing requirements, both implemented and proposed, send samples, coordinate and ensure follow through with GLP / FDA / EPA
  • Liaison with scientists of Agricultural Universities, GLP Test Facilities, FDA, EPA, OECD and other accredited agencies for country specific trials
  • Act as technical expert & participate in regulatory agency interactions
  • Effectively communicate in oral & written form, test requirements, regulatory issues and test deviations
  • Perform literature searches as appropriate for material submissions.
  • Overall responsibilities include consultation, assistance in report writing, literature searches, data gap analysis, product risk assessments, dossier preparation, customer correspondence, and consulting services for internal businesses.

Desired Candidate Profile

  • B. Sc / M. Sc / PhD in Chemistry with 7 to 12 years of experience in Global Registration in pesticide, chemical, pharmaceutical or related industry sectors
  • Well conversant with Good Laboratory Procedure requirements for and ability to communicate with 3rd party laboratories and other accredited agencies independently in US, EEC Countries, Middle East, Asia, Africa, CIS Countries, Latin America and Eastern Europe.
  • Knowledge of the chemistry and analytical technologies required for the development of new active ingredients, and formulated products including inert components.
  • Strong background in analytical chemistry with hands-on instrumental experience
  • Knowledge of spectroscopic and chromatographic techniques and chemo metrics
  • Knowledge of regulatory and data requirements for global agrochemical notification dossiers as well as emerging regulatory initiatives (REACH, ChAMP, Biocide Directive etc)
  • Practical experience in the formulation development of agrochemical products is desirable.
  • Knowledge of common PC-based software is expected, including word processors, spreadsheets, databases, web browsers, and statistical / mathematical software.
  • Profound English Language Competence is mandatory (expatriate experience is an advantage)

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ABOUT ORIGIN CONSULTANTS PVT LTD
which partners with Professional Organizations in a Human Resource Consulting Process aimed at Talent Acquisition, Recruitment and Selection of Organizational Leaders.
Headquartered in Mumbai, India, Origin Consultants Pvt Ltd focuses on Senior and Middle Management positions across and . Origin Consultants has established delivery teams and technology infrastructure at Pune, Bangalore, Chennai, Hyderabad and New Delhi.
With a Strong Network of Professionally Qualified and Experienced Candidates, Origin Consultants have conducted numerous successful Executive Searches for their Clients. Customers of Origin Consultants range from Startups to established Fortune 500 Clients and From the Largest Indian Corporations to Global MNC Multinationals.


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