You will be responsible for regulatory activities including approvals of NDA/BLA/Variations and maintenance, marketing authorization transfers, communication with the Health Authority, artwork approval, etc. ensuring regulatory compliance in the applicable market(s). As part of the IQVIA Regulatory Affairs & Drug Development Solutions (RADDS) (formerly Global Regulatory Affairs), you will be working with our clients – global pharmaceutical companies.
- Title: Regulatory Affairs Manager(Â÷Àå/ºÎÀå±Þ)
- ÀÚ°Ý¿ä°Ç:
v 7+ years regulatory expertise in country-specific requirements for medicinal products including the supervision and creation of country-specific regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority
v Knowledge of local pharmaceutical legislation, relevant guidelines and requirements
v Act as subject matter expert in regulatory processes
v Excellent regulatory project management skill set
v Regulatory technology experience is a plus
v Excellent written and verbal communication skills in English
- ±Ù¹«Àå¼Ò: IQVIA Àá½Ç/³²»ê ¿ÀÇǽº - Áö¿ø°æ·Î: Regulatory Affairs Manager (myworkdayjobs.com) - ä¿ë °ü·Ã ¹®ÀÇ: KoreaTA@iqvia.com - IQVIA ȨÆäÀÌÁö: https://www.iqvia.com/
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003