AddressPosition Description
Business Unit: PI R&D
Department: New Product Development
Location: Udaipur
Position Title: Team Leader - Regulatory Studies and Registration
Level: J2-J3
Reporting to (Title): Director Agronomy
Position Purpose
This position will report to Director New Product Agronomy and shall be responsible for coordinating the Regulatory Studies required for the development of new active ingredients with national and international CROs. The incumbent should closely work with Global Regulatory Manager for steering toxicology, ecotox & efate studies required for the new product registration in international market. The position should analyze and understand the outcome of eco-tox and e-fate Studies and timely guide the stake holders to take a right call on the project. The position will ensure that documentations with CROs are maintained appropriately in Signal notebook.
Strategic Responsibilities
Remain at the cutting edge of knowledge of ecotoxicology and e-fate studies essential for the new a.i. development activity in crop protection through constant updating of knowledge on new regulatory guidelines and own skill-sets.
Operational Responsibilities
Regulatory Activities
Coordinate for testing of new active ingredients against target insect/disease/nematode species for eco-toxicology and e-fate studies at domestic/international CROs locations.
Planning and coordinating payments, sample requirements of development & toxicology studies. Monitoring the development & eco-toxicology and e-fate studies study progress, data collection, analysis and generating insights.
Troubleshoot and suggest solutions to address scientific challenges encountered.
Present results and reports in cross-functional project teams and work across various projects / programs.
Documentation
Document and record findings in electronic notebook/research reports / papers for further dissemination / filing.
Process Adherence & improvements
Adhere to all safety / information security / quality norms related to research procedures.
Participate in process improvement initiatives under direction of Director – New Product Agronomy.
Present results in cross-functional project teams and work across various projects / programs Adhere to all regulatory / safety / information security / quality norms related to the NPD.
Participate in process improvement initiatives under direction of Director New Product Agronomy.
Financial Responsibilities
People Responsibilities
Lead professional development through continuous learning and development initiatives within and outside of the organization.
Collaborate with team members and cross-functional teams to ensure meeting of regulatory objectives.
Education Qualification
M.Sc / Ph.D in Science (eg Toxicology, Eco-toxicology, Chemistry, environmental fate) from a reputed University / Institute with excellent academic credentials.
Work Experience
Minimum of 2-3 years of post-academic industrial research experience. Preference for candidates with Project management
Industry to be Hired from
Agro Chemical companies, Contract Research Organization (CROs), first experience with agrochemical in Universities or Institutes
Functional Competencies
- Excellent knowledge of regulatory framework and requirements in registration of new products, label expansions and endorsements
- Through knowledge of crop agronomy, crop management practices, impact of pests on crops, integrated pest management techniques.
- Knowledge of Agrochemicals
- Project Management Skills
Interaction Complexity and Team Work
Interaction
Frequency
Purpose of Interaction
Internal : Global Regulatory Manager, India Regulatory Manager, Team Leader, Group Leader, Head - Biology, HR, Finance
As and when required
Planning work, discussing results of experiment resolving doubts, seeking clarifications on policy
reimbursement claims
External : Government bodies andInternationalCROs regulators
As and when required
For understanding regulatory requirements, interacting in forums.
External : Laboratories
Regular
Study planning, monitoring & resolving doubts
