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Position Title: Associate RA Manager, Drug
Responsibilities:
Develop and execute regulatory strategies for multiple complex programs related to import drug projects according to responsible therapeutic areas.
2. As a RA contact person to drive the regulatory input and support on the new import drug projects(NDA).
3. Work closely with the relevant stakeholders including R&D, BD, MA, Commercial, etc.
4. Obtain timely approval for new drugs and all other necessary approvals for the existing products maintenance.
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
6. Ensure regulatory compliance of regulatory activities.
7. Liaising with the relevant governmental bodies and regulatory authorities, such as NMPA, CDE, NIFDC, etc..
Response for assigned regulation & guideline shaping activity: develop external engagement activities with internal and external stakeholders, to build long-term and win-win relationship/partnership with external stakeholders.
Other tasks assigned according to work needs.
Qualifications:
1. Bachelor’s degree or above, major in Pharmaceutical or related major.
2. With minimum of 8-10 years’ work experience, incl. at least 3-5 years’ RA experience in MNC.
3. Excellent knowledge and competency in Drug registration and relevant technical guidelines.
4. Ability to manage complex projects and timelines in a matrix team environment and problem solving.
5. Ability to insure projects on time delivery with high quality.
6. Ability to independently identify regulatory strategy and risk with mitigation plan.
7. Good communication skill, creative thinking, with teamwork spirit; Result and detailed oriented and able to work under pressure to meet tight timelines.
8. Good written and spoken English + Mandarin Good Computer skill.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
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