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Willowood Chemicals

Compare

4.2

based on 127 Reviews

7 Willowood Chemicals Jobs

Regulatory Affairs Manager

Willowood Crop Sciences

4.2

based on 127 Reviews

5-9 years

Delhi/Ncr

1 vacancy

Regulatory Affairs Manager

Willowood Chemicals

posted 26d ago

Job Role Insights

Flexible timing

Key skills for the job

Regulatory Affairs Regulatory Compliance

Job Description

Supporting in both domestic and Export registration document preparation and submission of regulatory dossiers for agrochemical pesticide, herbicide Insecticide and fungicides.
Monitoring regulatory changes and requirements related to agrochemical products, and communicate updates to relevant clients.
Prepare and maintain regulatory documents, including product dossiers and technical reports.
Review product labelling to ensure compliance with regulatory requirements.
Report Evaluation of GLP and data review as per authorized guidelines.
Maintaining accurate records of regulatory compliance activities and ensure all documentation is complete and up-to-date.
Work closely with internal stakeholders such as R&D, Marketing, and Factory employee and Quality control persons to ensure products are in compliance with regulatory obligations
Participate in regulatory agency meetings and provide support during inspections and audits
Contribute to the development of regulatory strategies for new products and projects
Stay up to date with industry developments and changes in regulations related to agrochemicals
Provide regulatory support to other departments, including product development, marketing, and sales.
Assist in the management of regulatory projects to ensure timely completion and compliance with regulatory requirements.
Export Business:
Preparation and submission of dossier information to overseas countries, following EU compliance.
Eg: Philippines, Thailand, Saudi, Morocco, Japan, Taiwan etc
Analyze and interpret toxicity studies for endpoints viz. systemic toxicity, sensitization, genotoxicity, carcinogenicity, DART, etc. as per regulatory guidelines.
A strong understanding of global regulatory requirements, including FDA regulations, EU MDR/IVDR, and other regional regulations.
Extract and report data from various toxicology-related databases like NTP, JECFA, EFSA, SCCS opinion, US EPA regulations, PCPC/CIR, ATSDR, eChemPortal, IARC, etc.
To prepare and review Human Health Hazard Assessment Reports for chemicals.
Knowledge of medical device, FDA regulations and guidelines, European guidelines, risk associated with medical device, Biocompatibility studies and medical device, in vitro device regulation, Medical Device Registration, e-Submissions and Approvals in US, Europe and India.
MSDS/Safety Data Sheet, Toxicity Summary, Product Specification preparation, Technical Data Sheet and Technical Bulletin.
Review all GLP/Non-GLP study plan and Reports.
ADI and Classification of compound according to International Organization (FAO, WHO, EPA, EU, OECD)
Prepare and monitor budget for regulatory affairs expenses.