Sr. Regulatory Affairs Specialist
Coordinate and prepare documents for submissions to regulatory agencies worldwide, as appropriate by project.
- Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies’ guidelines for approval by Manager.
- Reviews submission-related documents from clinical, pre-clinical, research, development and manufacturing to ensure consistency with regulatory submissions and compliance with applicable regulations.
- Keeps abreast of current US and international regulatory practices, procedures and changes, as appropriate by project. Assesses impact of the changing regulatory environment to the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action.
- Participates in and/or represents Regulatory Affairs on project teams within defined projects.
- Maintains regulatory filings or records, including archive of submissions and FDA correspondences files.
- Actively participates in the development of regulatory strategies in conjunction with senior RA personnel.
- Assists with publishing or compilation of US, Canadian, EU and/or Latin America papers and/or eCTD submissions.
- Normally receives no instructions on routine work, general instructions on new assignments
- Perform other related duties as required
- Bachelor’s degree in a related scientific discipline with a minimum of 8 years regulatory experience in a biotechnology, pharmaceutical, or medical device company.
- Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Demonstrated communication skills (interpersonal, written, verbal, listening).
- Demonstrated time management (timelines, schedules, task prioritization).
Detail and accuracy oriented.