[바이엘 코리아] Regulatory Affair Specilaist(CS) 채용

Regulatory Affair Specilaist(CS)

 

 

 

 

 

 

 

업무개요

1. [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.

2. [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.

3. [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.

4. [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.

5.  [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.

6. [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.

7. [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.

8. [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.
 

응시자격

• 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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