The Regulatory Affairs Specialist will be an individual with experience in clinical study regulatory and compliance issues. A successful candidate will be highly motivated individual, self-started with an A+ attitude and proven ability to follow through who will be involved in managing agile/lean operations. The position will manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all study-specific synopses, protocols, TMFs, CRFs, IRB submissions and other regulatory documents including but not limited to IND submissions, NDA submissions, Annual Reports, etc.
The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- Develop and implement sound national and international regulatory strategies for multiple products.
- Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
- Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
- Write Annual reports, and other reports for the regulatory agencies
- Collaborate with responsible departments and leads preparation, review, and collection of documentation for regulatory submissions.
- Provide critical review of all documentation supporting regulatory applications.
- Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
- Review and approve ethics submissions keeping GxPs in check
- Work with peers to develop standard operating procedures and departmental guidelines.
- Participate as a full member of the R&D and clinical operations team(s) for the company’s products.
- Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
- Interfaces with regulatory consultants to drive the Company regulatory strategy.
- Review and approve protocols, reports, and documents used in regulatory submissions.
- Mentor regulatory associates and managers.
- Assume other relevant assignments as directed by supervisor.
- Maintains the strictest confidentiality of all activities.
- Team player, engendering credibility and confidence within and outside the company.
- Faithfully performs any other tasks requested by the Chairman, President & CEO.
- Act in accordance with Landos’ policies and in alignment with the corporate culture.