Regulatory Executive

3 weeks ago

Bengaluru, India UPL ltd Full time

**Regulatory Executive**:

- Job Id: 6413- City: Bangalore, Karnataka, India- Department: Regulatory- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Executive- Description:
**JOB DESCRIPTION**

**Reviewed on: 7-1-22**

**BUSINESS UNIT
NPPL India

**SUB-BUSINESS UNIT**

NPPL

**FUNCTION**

NPPL R&D & Regulatory

**SUB FUNCTION**

NPPL Regulatory

**DEPARTMENT**

NPPL Regulatory

**JOB TITLE**

Executive Registration - Bio-Solutions

**GJL**

1A/2B

**POSITION REPORTING TO**

Principal Scientist

**REPORTEES**

Direct Reportees: 0

Indirect Reportees: 0

**Base Location**

Bangalore

**Purpose of the Role**:

- Regulatory support for registration of Bio-solution products, globally
- Handle entire gamut of registration in assigned countries/region
- Study/data sponsoring & monitoring - in-house and externally (research centres/CRO’s)

**Responsibilities**:

- Timely co-ordination with R&D scientists, Analytical teams, QA, Mfg. & SCM teams to generate and support regulatory/product technology documentations and product samples
- Assist to sponsor and monitor studies (lab & field) at GLP CRO’s/Labs/Field Institutes for their timely availability
- Responsible to handle entire gamut of registrations in assigned region in co-ordination with regional regulatory teams
- Co-ordination with region to understand and develop regulatory framework to register bio-solution products (rules, regulations, data requirement, guidelines, process, time and cost required)
- Timely attend registration deficiencies and renewal of registrations in assigned country/region
- Keep track and monitor of regulatory field studies conducted in-house & at CRO’s/Res. Institutes
- Provide technical support to region to register bio-solution products
- Work closely with all other internal key functions & outside customers for creating regulatory, safety documents for assigned regulatory portfolio.
- Handle data evaluation, data gap and investment analysis for new products and existing products for geographical expansion.
- Regulatory budget creation for assigned region in co-ordination with region and its monitoring
- Close co-ordination with NPPL portfolio/marketing to generate regulatory capexes and fast track their approvals
- Management of CRO invoices and payment
- Create regulatory data Masters related to assigned region/country and its time to time updation.
- Maintain all regulatory records related to assigned territory
- Close co-ordination with IPD/IPR teams for FTO clearance
- Project Life cycle Management in assigned region
- If required, should travel to HO, in field, countries/region for regulatory work

**Qualification**:

- M.Sc (Agri) Pl. Pathology/Entomology/Agronomy, MSc in Biological sciences
- 2-4 years of relevant experience
- Knowledge about Agro biopesticide / biological iindustry, Regulatory norms & documentations

**We are one team, for maximum impact. One team with shared goals. We all play for the team and no one plays against the team. We have a laser-like focus on what our customers need and want, on anticipating their future needs and on how we can create innovative solutions and experiences for them.**

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