유망벤처, 임상 RA (3년이상, 재택가능)
본문
[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
[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
