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Open Position

Open Position

Healthcare 기업에서 Sr. RA Manager & Asso RA Manager 각각1명씩 채용합니다.

  • 2021-08-20 15:05:00
  • 1.223.120.93

DUTIES AND RESPONSIBILITIES

  • Lead and manage a team by setting objectives and goals, conducting performance reviews and development plans, providing support, training and mentoring
  • Ensure submission requirements are communicated to relevant regional and global support teams for applications planned by team
  • Keep APAC RA Director informed of progress of applications and issues impacting applications, supply, compliance, etc…
  • Responsible for developing and implementing regulatory strategy aligned with business strategy
  • Implement policies to ensure ongoing compliance of regulatory requirements
  • Provide direct supervision of individuals including mentoring, performance management and staffing decisions
  • Support ongoing marketing strategies via registration of new products meeting corporate/business requirements
  • Maintain marketing authorizations for existing products
  • Compile and submit, in a timely manner, regulatory submissions according to requirements
  • Ensure the maintenance of licences and permits where applicable
  • Ongoing identification of optimisation of procedures and guideline development where required
  • Ensure staff are trained in regulatory matters based on current standards and guidelines to keep them up to date with changes to requirements
  • Keep up to date with changes to regulations and standards and advise local, regional and global colleagues of the implications of such changes
  • Review existing procedures and databases in conjunction with Regulatory staff, and implement value added improvements identified, and/or update according to corporate procedures
  • Other tasks as directed by RA Director
  • Team leading - Provide direct supervision of individuals including mentoring, performance management and staffing decisions.
  • Monitor, evaluate, and interpret all applicable regulatory requirements and assure compliance with Baxter and external standards
  • Review and Approve the promotional materials and provide the consultation for compliance with local and global regulations
  • Manage and maintain operational activities (planning, management of budget)
  • Communicate/collaborate with SBU marketing and other functions primarily at the project team level
  • Proactively interact and negotiate with regulatory bodies on complex issues 
  • Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks in area for regulatory decisions   

 SKILLS & QUALIFICATIONS

 

  • Sound basis of scientific knowledge
  • Expert knowledge of regulatory regulations and guidelines
  • Established relationships with regulatory authorities
  • Risk identification and problem solving skills
  • Strong negotiation skills and significant experience in interacting with regulatory authorities, industry associations, internal and external stakeholders
  • Ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment
  • Demonstrated ability to lead, mentor, and develop others for future growth and development

Qualifications

  • Bachelor degree in Pharmacy or related scientific discipline; postgraduate qualifications in business or related areas will be an advantage
  • Minimum of 8-year experience in Regulatory Affairs in Korea pharmaceutical/medical device industry including at least 3 years experience in managing people
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