Gm Regulatory Affairs - Coimbatore, Tamil Nadu, India - T AND COMPANY LIMITED
Description
1.Interact with the policy makers for regulatory guideline development for novel /new products & on the technical data requirements for the products under the category of Bio-stimulants, Biopesticides & Biofertilisers.
Develop and implement regulatory and public policy advocacy strategies along with external industry associations & have continued interaction with the associations in amending the guidelines of the regulations issued by INM (MoA) under FCO for Biostimulants.
- Monitor the preclinical studies that are in progress and conduct technical review of the ongoing/ to be undertaken toxicological studies & the data developed at GLP labs for all the products, before submission.
- Provide regular updates on the new inclusions; pre-requisites for registration of new & novel products as per the conditions enforced by the regulatory bodies (CIB-RC, FCO, OMRI) & scientific organizations (TERI, DBT etc.,) and on the amendments in the existing regulations.
- Oversee the renewal of all relevant certifications (ISO, DSIR, OMRI, Organic certification & BIS) required for product endorsements & accreditations of the manufacturing units. Provide technical inputs on the raw materials & processes to enable organic certification of newly developed products.
- Preparation/submission of dossiers & regulatory guidance to the marketing team on viable operational activities & advice on the regulatory options for registration of all products manufactured/outsourced by the Company.
- Interacting with the Toxicology Institutes/GLP/NABL labs for developing data, complying with the requirements, as per the guidelines of OECD, EPA and EU, for registration in India / USA / EU / African and Arabian countries
- Identifying the potential areas of research & collaborative research projects for development of products for Agricultural use by systematic review of research publications & information on the new products launched in market.
- Consolidation of the projects carried out at the R&D & render advice on the regulatory requirements for the pipeline products & futuristic innovative biotech products.
- Develop stratagem for promoting & commercializing the testing activities.
- Technical support to all product developmental/promotional activities( for Export /Domestic markets); & review of the adequacy of the data required for overseas registration before submission.
- Visits to CIB & other regulatory boards in coordination with the Company's consultant, to update & track the progress of registration process.
Salary:
₹1,000, ₹1,500,000.00 per year
Benefits:
- Cell phone reimbursement
- Health insurance
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Coimbatore ,
Tamil Nadu:
Reliably commute or planning to relocate before starting work (required)
Education:
- Doctorate (preferred)
Experience:
- total work: 10 years (required)
Speak with the employer
- Health insurance
More jobs from T AND COMPANY LIMITED
-
Machine Operator
Coimbatore, Tamil Nadu, India - 1 week ago
-
Stores Incharge
Coimbatore, Tamil Nadu, India - 4 days ago
-
Supervisor
Coimbatore, Tamil Nadu, India - 1 week ago
-
Gm - Seeds
Coimbatore, Tamil Nadu, India - 1 week ago
-
Payroll Executive
Coimbatore, Tamil Nadu, India - 4 weeks ago
-
Sales Officer
Coimbatore, Tamil Nadu, India - 4 weeks ago