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Overview:
The Regulatory Specialist / Senior Regulatory Specialist is primarily responsible for creating and compiling submissions to regulatory authorities, assisting product team leads with project specific work, actively managing and supporting assigned regulatory projects, and supporting Medical Writing with the compilation of regulatory documents. This position will also collaborate with other departments within the company.
The Regulatory Specialist / Senior Regulatory Specialist will also participate in, or lead, regulatory submission project planning meetings and ensure diverse, complex documents are processed in a timely manner, with minimal errors, while complying with internal SOPs and various regulatory agency guidelines and regulations. In addition, this position will independently prepare routine IND amendments (e.g. annual reports) and New Drug Application (NDA) supplements in accordance with guidance documents, internal and external, and assist Regulatory Affairs management with preparation of formal meetings with regulatory authorities, including Food and Drug Administration (FDA) and Health Canada meetings, Advisory Committee Meetings, etc., as requested. The Regulatory Specialist / Senior Regulatory Specialist will also proactively communicate project status and issues to management and provide solutions for project and schedule issues. Medical Writing will also be a responsibility of this position through assisting with compilation of clinical study reports’ appendices and QC regulatory documents, e.g. clinical study reports, Integrated Summary of Safety, Integrated Summary of Efficacy, Safety Updates and briefing documents.
Responsibilities / Qualifications:
We seek a candidate with experience with regulatory submissions including producing and formatting paper/electronic submissions for regulatory agencies, e.g. Investigational New Drug applications (INDs), common technical documents (eCTDs), premarketing approvals (PMAs), amendments, supplements, and annual reports.
A Bachelor's degree in a related field is required, science-based is preferred, with 4+ years of direct experience within the pharmaceutical environment. We seek a candidate with a working knowledge of FDA regulations and experience in international regulations is a plus. Strong oral and written presentation and communication skills are also required. We seek a candidate with strong interpersonal, teamwork, organizational and time management skills. The successful candidate will have intermediate skills in Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations. The ability to act independently and to take initiative on a daily basis is a must.