업무개요
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Regulatory Affairs- Product registration
※ Manage the product registration -
Prepare dossier, Submit dossier, and Achieve Registration for New,
Label extension, and Re-registration - and aligned with project
timeline.
Contact to RDA and KFDS for Registration & other related matters to
ensure full compliance of
local law & regulation.
Monitor/Update related regulatory guidelines.
- Regulatory Affairs- Quality management by KFDS and RDA Requirement
※ Manage to fulfill the local KFDS requirement for
product quality(incl. Quality test organizations)
and quasi-drug warehouse via managing import product, Product Quality, and
stock inspection to comply with
Bayer and local regulation. Manage development of labelling for new and
existing products in all segments
to comply with Bayer and local regulation.
- Product & Portfolio Development
※ Coordinate to develop new products and portfolio
introductions for customer needs and strategy fit.
Coordinate project teams, and utilizes process optimization, project
management and technology tools.
Coordinate Developments of technical timelines for projects, incorporating
tasks, dependencies, and costs into the overall project and pre-project
plans.
- Portfolio, Trial & Project Management
※ Coordinate the product development trial with
external parties (research center, association & university)
to achieve business objectives within timeline. Report all the trial results,
analyze and interpret trials data
from all sources provides technical summaries to enhance registration &
national sales efforts through the interim/annual review meeting.
- Technical Support- Trial
※ Coordinate the operation for external cooperators
for demonstration trials
(look&see, development trial& demonstration trial).
Plan and implement the ES Korea development and technical service programs in
support of the all customer segments.
- Technical Support – Communication with Customer
※ Training technical of New/Amend Products for
internals(Marketing and Sales) & externals(Business partners and
individual end user) and provide Technical support to establish
or enhance correct (re)positioning of product(s) for maximum market
penetration and protection of market share for the customer market.
Provide feedbacks on needs / issues of customers (Green and White) to ES.
- Sample Management
※ Manage samples for all trials such as Registration
trials, Look & see trials and Demonstration trials and Quality test
to comply with Bayer and local regulation.
- Stakeholder Engagement
※ Communicate external stakeholders such as
regulatory authorities, leading universities, research centers
& associations to ensure project timelines, trial results, and
registration dossier will be accepted by RDA & KFDS and customers
(Golf courses, PCOs and Partners) to ensure product reposition, Market
Penetration/Protection for customer needs.
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응시자격
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Bachelor degree with Pharmacy (including Pharmacist certification) and prefer
2 years relevant experience in regulatory affairs
- Ability to analyze technical data and understand fully the requirements of
the regulatory authorities in Korea
- Proficiency with project management techniques and skilled in
organizational matrix interactions.
- Technical expertise and extensive knowledge in all Environmental Science
business areas.
- Thorough knowledge of competitive products, major commodities, their location
and an ability to analyze how new products fit in the marketplace.
- Effective interpersonal skills for interfacing with other Bayer,
university, regulatory department, association and customer personnel.
- Excellent communication skills, both oral and written, to communicate
clearly his/her thoughts, ideas and direction.
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