美国招聘Manager in Regulatory Operations-homework

公司背景：

• 国内知名上市药企，在加州和马里兰具有site。
  

• 最低要求本科，5年以上相关经验

• 汇报对象是外国人，可以在家办公
  

Description:

Provide guidance, plan, and support the Regulatory Affairs Strategists in operations, formatting, and publishing regulatory submissions. This individual will be well-versed in regulatory requirements for eCTD formatting, publishing, and troubleshooting. Additionally, the PM is responsible for preparing granular timelines per consult from various functional groups and RA lead, and enforce the timelines, collate comments, arrange meetings, take detailed meeting minutes, and archive regulatory documents per established standards.

Major Duties and Responsibilities:

· Compilation, consolidation, and publishing of regulatory submissions to FDA and possibly other health authorities

· Advanced skills for formatting and publishing regulatory documents, using applicable software tools

· Stay abreast of requirements and update for eCTD publishing to FDA for different types of submissions

· Provide and enforce granular timelines in various stages of preparing and submitting regulatory applications

· Establish and maintain the regulatory operations including timely archiving and maintenance of all regulatory documents

· Create and maintain filing systems and other records management solutions as necessary

· Create and actively maintain templates for regulatory documents and submissions

· Initiate projects and proposals that improve systems, regulatory processes and operations, and increase the efficiency of regulatory activities

· Keep track of status of all filings including maintenance of submissions

· Enforce policies related to internal and external document formatting and regulatory publishing requirements as well as industry/regulatory authority best practices

Qualifications:

· Minimum of Bachelor’s degree preferred

· Preferably a degree in biomedical sciences, regulatory science, or clinical research/operations

· Advanced knowledge of US regulatory requirements

· Knowledge of overall drug development process

· Minimum of 5 years pharmaceutical/biotechnology industry or regulatory agency experience

· Minimum of 5 years of project management experience

· Experience in regulatory publishing/operations/archiving

· Detail-oriented, organized, multi-tasker, critical thinker with excellent oral and written communication skills

· Must enjoy working in a fast-paced, cross-functional, dynamic, small company setting with aggressive timelines and supporting multiple projects simultaneously

· Has customer service approach and seeks solutions to challenges and problems

· Must be able to work independently and willing to continuously learn and tackle challenges