[Regulatory Affairs Specialist]
[담당업무]
- Input into product and company compliance with local/international regulations 
- Input into preparation, compilation and submission of regulatory documents such as formal   meeting packages, IMPD/IND/CTN and BLA/MAA/NDA
- Provide relevant regulatory consultation and insight to internal functions
- Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
- Participate in regulatory and/or clinical trial project teams as required
- Plan and track designated project activities including financial tracking under supervision
- Produce accurate, complete and professional correspondence, including meeting minutes, as assigned within designated timelines across project meetings
- Work closely with Project Management team to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department goals
- Effectively contribute to all the aspects of allocated projects in timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Managers/Directors
- Communicate/liaise with CROs, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required
- Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals 
- Travel (approximately 30%) domestic and/or international
- The individual may be asked to perform other duties
[지원자격]
- Bachelor’s Degree or higher graduate degree from the Medical/science/regulatory background and/or discipline
- 3+ years of professional experience in regulatory affairs in biopharmaceutical industry
- Experience in communicating with US FDA/EMA/EU NCAs/PMDA/MFDS as the main contact for initial IND, IND amend and notification preferred
- Knowledge of local/global regulatory requirements/guidelines and global standards, mainly for biological products 
- Good interpersonal communication skills 
- Excellent written and spoken English and fluency in Korean
- Competent computer skills