- Bachelor's Degree
- Master's Degree
Job Summary (Primary function)
The Manager/Senior Manager, Global Regulatory Affairs is responsible for day-to-day coordination and preparation of regulatory submissions. The Manager will work and interact with internal cross-functional team members in order to create regulatory submission documents that are compliant with US FDA and/or global regulatory requirements.
Essential Functions of the Job (Key responsibilities)
Manage the creation, review, and submission of IND and/or CTA regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, etc.) to support product development and clinical trials in the US, EU, Canada, and rest of world as necessary.
Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
Collect reports and documentation and coordinate the content and format of submissions according to FDA and other global health authority requirements.
Create regulatory submissions from internal reports (e.g. clinical, non-clinical, and adverse events).
Maintain current knowledge of relevant US and international guidance, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
Ensure that dossiers containing technical, preclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
Ability to read and understand all components of a regulatory submission (IND/NDA) to ensure consistency across documents.
Coordinate the preparation of responses to questions and inquiries from health authorities.
Liaise with FDA and other health authorities as needed (e.g. telephone contacts, teleconferences, meetings, submissions).
Excellent communication skills; both oral and written.
Strong interpersonal skills with the ability to influence others in a positive and effective manner.
Demonstrated ability to contribute to a continuous learning and process improvement environment.
Excellent analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.
Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.
Other responsibilities, as required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related field preferred. Regulatory Affairs (RAC) Certification is a plus.
A minimum of 4 to 6 years’ experience in regulatory affairs and/or early stage drug development experience.
In-depth knowledge of pharmaceutical drug development, and regulations/ guidelines governing development of pharmaceuticals.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.