Job Summary
The Associate Director, Regulatory Affairs works in collaboration with the Director, Regulatory Affairs to develop strategy and ensure regulatory requirements for assigned products are complete. The Associate Director is also responsible for day-to-day coordination and preparation of regulatory submissions and 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. The Associate Director will collaborate with the Director, Regulatory Affairs to lead meetings with FDA and other Health Authorities.
Essential Functions of the Job (Key responsibilities)
- Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents etc.) to support product development, clinical trials, and marketing applications in the US, EU, Canada, and rest of world as applicable.
- Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
- Ability to read and understand all components of a regulatory submission (IND, CTA, NDA, MAA, etc.) to ensure consistency across documents.
- Ensure that dossiers containing technical, nonclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
- Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
- 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).
- Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
- Maintain current knowledge of relevant US and international guidance’s, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
- Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
- Keep employees informed of relevant regulatory guidance documents, regulations and information.
- Strong 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.
- Strong 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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor’s or advanced degree (e.g., Ph.D., Pharm.D.). Scientific/life-sciences degree a plus. Regulatory Affairs (RAC) Certification is a plus.
- A minimum of 3 years direct responsibility for regulatory affairs with at least 5 or more years of drug development experience.
- In-depth knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.
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.
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