Automated Systems, Inc. A

Regulatory Affairs Associate

Found in: Jooble US

Description:
This role resides within the Regulatory Operations- RA Systems and Submissions Operations organization.
  • Drive integration and transition of products into regulatory operation processes.
  • Project team member representing Regulatory Affairs Operations, driving timelines and deliverables related to submission documents.
  • Primary Regulatory Operations liaison to internal and external groups, including regulatory authorities on electronic submissions and documentation systems.
  • Regularly interacts with RA management and functional peer groups inside and outside the department.
  • Interacts internally and externally to influence policy and strategy. ​
  • Provide system and process support, development and training
Requirements Education and/or Experience:
Bachelor's Degree or country equivalent with a minimum of 7 years in a regulated environment Qualifications:
  • Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processes
  • Hands on experience with electronic submissions and eCTD (INDs, BLAs. NDAs)
  • Expert skills in electronic publishing/document/data management systems (e.g. Documentum, ISI Toolbox, eCTD Xpress and database creation/management)
  • Sound basis of Regulatory knowledge
  • Scientific Knowledge
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong oral and written communication and presentation skills
  • Demonstrated interpersonal skills including strong negotiation skills Top soft skill for this role: Collaborative Attention to Detail Flexible/Adaptable Strong Communication Work ethic
Job Requirements:
Support regulatory compliance and submissions Filing documents related to regulatory submissions Ensure compliance to existing regulatory submissions Preparing regulatory documents and/or submissions Submit regulatory applications and internal regulatory file documentation Verify compliance with regulatory requirements Ensure compliance with regulatory requirements Assure compliance of regulatory files Providing regulatory and compliance guidance Prepare submissions and reports for regulatory agencies Ensure compliance to regulatory standards Support and ensure regulatory compliance Discuss regulatory issues and submission requirements Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions Maintain regulatory records for regulatory activities and applications Prepare regulatory document submissions and timely submit Review of regulatory quality documents Compile and maintain appropriate technical documents for regulatory submissions Assure global regulatory compliance of company products

calendar_today 3 days ago



location_on Bannockburn, United States

work Automated Systems, Inc.

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