Bristol-Myers Squibb ir jobs (salary & requirements)

• Ensure regulatory compliance with government policy company required SOPs
• Develop the regulatory CMC strategy of assigned products based on local regulatory requirements, ensure local regulatory strategy is aligned with TA strategy consistent with global product strategy local priorities
• Develop maintain the good life cycle management plan of assigned products timely communicate with internal external key stakeholders to allocate of adequate resources deliver plans on time
• Ensure good execution fproduct lifecycle management including renewals, variations other registration/commercial activities through timely submission approval with a high standard
• Identify risk areas develop alternative sources of action, including anticipation of regulatresponses through scenario planning contingency plans.
• Monitexternal changes in the regulatory environment that will impact on the CMC requirement, timely communicate the impact of changes to key stakeholders
• Maintain strong working relationship communications with internal external key stakeholders.
• Establish maintain close relationship with NMPA/ CDE/ NICPBP other appropriate regulatory agencies have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status facilitate the approvals of applications submitted to NMPA.