Covance

Global Regulatory Affairs Strategy Director - Korea

Job Location(s) KR-Seoul
Job Number
2021-77235
Job Category
Regulatory
Position Type
Full-Time
Telecommute
No

Job Overview

 
Are you ready to take your career forward?
 
This leadership role is highly visible within the global Covance by Labcorp business and is central to delivering Labcorp's value proposition to potential clients in Korea.  This positon is required to partner with key internal stakeholders as well as client and regulatory agency (MFDS) contacts to assist with the regulatory affairs strategy for clinical trials. 
 
Responsibilities include:
- Collaborate closely with internal Labcorp project teams in the design and development of regulatory strategies for client projects or to answer client inquiries.
- Collaborate with the rest of the Global Regulatory Affairs Strategy group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise.
- Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by MFDS, FDA, and elsewhere. 
- Interact and collaborate with all internal business unit personnel
- Establish productive working relationship and collaborate closely with Regulatory Submissions staff.
- Create and build confidence by representing the regulatory strategy function as an informed, capable, knowledgeable, responsible and accessible resource to Covance by Labcorp staff, management and clients, positioning Labcorp as a preferred source for regulatory strategy expertise.
- Build successful working relationships with business and scientific leaders across the organisation.
- Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.
Why join Covance by Labcorp?
 
For starters, we’re the most comprehensive CRO in the industry (Drug development through to post marketing surveillance). What else makes us different?
- Exceptional experienced employees working together in a culture that emphasizes continuous learning and rewards success
- Supportive global leadership that provide you a platform to develop and grow your experience.
- Be part of a global team that works on wide range of therapeutic areas from Phase I – Phase IV
- Join a friendly welcoming culture with opportunities to work from home
- Be valued – partner with key regional leadership stakeholders to recommend and develop localized strategies to meet business and client expectations

Education/Qualifications

- An advanced degree with a focus in life sciences is required, an Phd/MD preferred.  

Experience

- The ideal candidate will possess 8-10 years experience of drug development in the Pharma, biotech or CRO industry with at least 6-8 years experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.

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