Regulatory Affairs Associate
Automated Systems, Inc.
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.
Education and/or Experience:
Bachelor’s Degree or country equivalent with a minimum of 7 years in a regulated environment
• 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:
- Attention to Detail
- Strong Communication
- Work ethic
- 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