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Manager - Regulatory Affairs
About Job
The client organization is entering into JV towards introducing herbicide resistant rice and wheat varieties in India. However, quite a few of these herbicides will not be approved for use over Paddy or wheat, In India. Hence, it renders these rice and wheat varieties or very limited use in India. Inorder to overcome this challenge this individual, an expert in driving registrations of herbicides in India, will ensure the relevant herbicides are registered in a timely manner with nationwide acceptance as well as liaisoning with various govt depts. The criticality of this role can be assessed from the fact that the whole business proposition and USP of herbicide resistant varities falls flat if these herbicides do not get approval for use on paddy crop.
Job Description
Key Responsibilities:
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Liaise with regulatory agencies/ authorities viz. Central Insecticide Board, Directorate of Plant Protection, Quarantine & Storage etc.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare documentation for getting the approval for new herbicides – private label claims.
- Prepare documentation for new applications of existing/ approved labels.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submission.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed labeling changes.
- Participate in internal or external audits.
- Compile and maintain regulatory documentation databases or systems.
- Write or update standard operating procedures, work instructions, or policies
Salary: Best in Industry
Job Location: North India
Job Details
- Industry
- Food, Agribusiness & Allied
- Segment
- Seeds & Agri Biotech
- Job Level
- Senior Management
- Salary
- Experience
- 13 - (in years)
- State
- Country
- India
- Reporting To
- Company Name
- Company Size