[바이엘 코리아] Regulatory Affair Specilaist(VA) 채용

Regulatory Affair Specilaist(VA)

 

 

 

 

 

 

 

 

업무개요

1. Position purpose (A brief statement indicating the basic urpose of the position)

• To obtain, maintain, and change the product registration in line with business strategy and regulatory compliance

 

2. Major tasks and responsibilities of position (max. 8 key topics)

(1) Estimate and evaluate regulatory environment or requirements and take appropriate action

(2) Set-up registration strategy and update milestone plan on a regular basis for assigned products

(3) Compile and submit the application for marketing approval and maintenance of product licenses

(4) Coordinate registration support studies and control planned schedule and costs

(5) Support Regulatory affairs manager to achieve the strategic objectives of VA

(6) Ensure regulatory compliance in line with global standard and local regulations

 

3. Work relations (List the most important work relationships with internal and external partners/customers)

(1) Internal

- Assist or co-work with RA manager for assigned tasks by Head of VA

-Cooperate with product managers, veterinary experts, QA/QC, and other relevant department as well as global partner in HQ for assigned product registration

 

(2) External

- Build good relationship with the authorities and communicate appropriately with them

- Keep contact with key researchers and coordinate registration support studies

- Attend industrial meeting with regulatory topics

- Closely communicate with counter partners of 3rd parties and affiliates

 

 

응시자격

4. Qualifications (Education, skills, experiences and personal characteristics necessary for success in this position)

(1) Education:

- Bachelor degree or above (master degree is preferred)

- Major in veterinary medicine, pharmacy, or life-science

 

(2) Experience:

- More than 1 year experience in animal health or pharmaceutical field

- Experience in medical/regulatory affairs is preferred.

 

(3) Knowledge & Skills:

- Scientific knowledge on veterinary medicine or pharmacology

- Good communication skill with internal/external customers

- Good written and spoken English

 

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