Job Title: RA Director
Report to: Global RA Head
- Ensure all clinical trials are executed in compliance with domestic and international GCP guidelines/regulations and applicable SOPs.
- Oversee coordination and planning of interactions, communications and submissions to relevant regulatory authorities in North America and ethics committee, as appropriate.
- Provide direction of CRO and consultant activities performed for company clinical programs as related to regulatory submission activities, including management of submission strategy, content and timelines, as well as identification and resolution of any performance issues for the CRO services.
- Participate in development and writing of INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents Direct the preparation and submission of regulatory agency applications, reports and all other correspondences.
- Oversee documentation for regulatory submissions to ensure compliance with domestic and international regulations and standards.
- Identify and guide the cross-functional project team relevant for requirements for submissions, ensuring accuracy, consistency and completeness while adhering to regulatory standards, SOPs and guidelines as appropriate.
- Develop, manage and maintain regulatory affairs SOPs; implement regulatory affairs policies and procedures to ensure regulatory compliance is maintained.
- Participate in evaluation of system for internal file storage for all regulatory submission and correspondence documents and implement controlled document management.
- Participate in the development of departmental timelines, as well as review and approval of relevant vendor invoices.
- Functional representative on project and/or study teams, leading by interacting with multi-disciplinary teams for preparing relevant regulatory tasks.
- Proven organizational skills with the ability to prioritize and work with a sense of responsibility in an environment with competing demands. Ownership and accountable for functional deliverables.
- Regulatory Affairs experience in biopharmaceutical industry and knowledge of relevant regulations and requirements pertaining to clinical trials.
- Motivated, ability to adapt to small-company’s hands-on culture and willing to learn new things.
- Proactive and well-organized, ability to plan, focus, coordinate and monitor activities according to priorities, established schedules and deadlines.
- Teamwork spirit, strong interpersonal skills, with an ability to communicate and influence key stakeholders at all levels effectively.
- Knowledge of ICH, GXPs, Data Privacy and other applicable regulations and requirements in the pharmaceutical industry.