Regulatory Submissions Specialist

Job Summary:This position within Regulatory Affairs is responsible for assisting in the preparation and tracking of submissions to the FDA as well as providing support for submissions to the TPD in Canada. The incumbent will draft and reformat documents for FDA submissions and will assume responsibility for tracking the large number of documents in/out of the Submissions Group, including the new responsibility for tracking "subdocuments" that are part of the CTD format.EOE(m/f/d/v)Job Responsibilities: Responsible for assisting in the preparation, submission, distribution and archiving of all FDA submissions. Assist in the establishment and maintenance of SOPs for the Submissions Group consistent with evolving FDA guidelines for electronic submissions. Work closely with Corporate QA/QC/Compliance to ensure that the systems accommodate the needs of quality assurance audits of submissions. Provide resources as requested in support of Astellas Pharma Canada in their submissions to the TPD. Provide support to Regulatory Affairs for the creation of complex documents (e.g., CMC summaries, supplements, amendments, annual reports). Prepare and maintain templates which meet Astellas Pharma US, Inc. and regulatory electronic submission standards. Update templates in accordance with the most current FDA and ICH regulations, guidelines and initiatives. Interface with other APUS/API/APERD personnel as required in order to support the document management processes. Act as a liaison between members of Regulatory Affairs, CCQ, and Submissions in order to ensure timely submission of regulatory-compliant, quality documents. Assist as needed in the preparation of IND and NDA technical sections, briefing documents, Advisory Committee materials, and FDA responses. Track and coordinate document timelines. Consult with RA personnel on ad hoc technical writing issues (e.g., format, content, Microsoft Word troubleshooting). Participate in core/working team meetings as/when necessary. Responsible for maintaining state wholesaler, manufacturer and distributor licenses in compliance with federal regulations.
REQUIREMENTS
Job Requirements: Bachelors degree (life sciences, chemistry or biology preferred) or equivalent related experience required. Minimum two years related work experience desired, pharmaceutical industry or in a clinical setting preferred. Demonstrated computer skills in Microsoft Office (e.g., advanced functions in Microsoft Word) required as well as Adobe Acrobat. Experience with document management systems and publishing systems, such as Documentum and docuBridge, highly desirable. Excellent communication skills including written skills. The ability to be flexible and to work on multiple projects simultaneously. Able to handle stressful situations including meeting timetables on his/her own assignments at the same time as assisting other members in the Submissions Group.Skills: Adobe Acrobat, Microsoft Office, Capable of Multi-Tasking, Effective Time Manager, Flexibile and Open-Minded, Verbal Communication Skills, Written Communication Skills