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Associate Regulatory Affairs Manager
AstraZenecaTaiwan30 天前
工作型態
- serp_jobs.job_card.full_time
職務描述Leads Submission Management with cross-functional teams, ensuring they comply with AstraZeneca’s submission-ready standards Provides expertise, guidance, and awareness to cross-functions in support of dynamic Health Authority eRegulatory requirements Ensures business support needs and Information Systems demands are identified and addressed Ensures that key business needs identified by the project are efficiently and effectively addressed Identifies required project resources and communicates these to line management and ensures line management is aware of changing project timelines Takes responsibility for training together with line manager, Provides knowledgeable, professional, and interactive representation on industry or internal forums to ensure AstraZeneca’s eRegulatory interests and requirements are communicated and incorporated into key decisions Develops and maintains strong partnerships with key internal and external stakeholders, , Regulatory Health Authorities, Industry Reps., etc. Complies with or is aware of all relevant AstraZeneca policies University degree in pharmacy related field Leadership Skills leading cross-functional, international project teams Excellent written and verbal communication skills in English Thorough knowledge of health authority requirements on Regulatory technical format requirements including processes and technologies Experience managing resource requirements for regulatory projects Good negotiation skills Good team working capabilities Proven Project Management skills
Responsible for preparation, publication, quality control, and delivery of all submissions and works on complex technical problems. Implements strategies to improve quality and efficiency of submissions and ensures regulatory compliance with local legislation, global regulatory policy and SOPs.
Core Accountabilities
- To strategically communicate, plan and execute submission plans while ensuring cross-functional alignment on submission prioritization and timelines.
- To implement submission plan to obtain and maintain regulatory approval of product registration in Taiwan and work according to Good Regulatory Practice (GRP)
- To liaise with International Regulatory Affairs and local Regulatory Authourities to ensure full regulatory compliane of the company.
Major Responsibilities
Qualifications
Essential
Desirable
Date Posted
11-Jun-2024
Closing Date
16-Sep-2024