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Gm Regulatory Affairs

2 weeks ago

Coimbatore Tamil Nadu, India T.STANES AND COMPANY LIMITED Full time

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

7. 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.

8. Consolidation of the projects carried out at the R&D & render advice on the regulatory requirements for the pipeline products & futuristic innovative biotech products.

9. Develop stratagem for promoting & commercializing the testing activities.

10. 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.

11. Visits to CIB & other regulatory boards in coordination with the Company’s consultant, to update & track the progress of registration process.

**Salary**: ₹1,000,000.00 - ₹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 - 641018, 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**
+91 9142221514
- Health insurance