Top Director

The position is the Head of the Regulatory Operations Group in the Regulatory Affairs/ Quality Assurance Department (RA/QA). The person supervises, coordinates and prioritizes Halozyme's regulatory submissions. The position requires close collaboration with the RA/QA staff in representing the submission needs in the form of documentation, templates and formats. The position will be the primary contact for Regulatory Operations to the Project and Program Teams. The individual will be proficient in and with hands-on experience with eCTD submissions and will be able to participate as an individual contributor in the preparation of eCTD submissions during peak periods. The person is the main contact with regulatory authorities for Regulatory Operations questions and will stay abreast of latest regulations, guidances and trends in the area of electronic submissions and ensure that the Halozyme Regulatory Operations group is operating in conformance with the latest standards. The position requires experience in the area of document management and familiarity with EDMS systems and electronic formats and platforms necessary to effectively and efficiently prepare regulatory documentation ( Adobe, PDF, backbone structures, SAS data files, study tagging files, electronic gateway etc.). The Head of Regulatory Operations will support Halozyme with the development and implementation of a scalable document management system that will serve across Halozyme's departments

Required Skills

• Hiring, staffing, and development of RA Operations staff .
• Supervision, mentoring, training and development of the Regulatory Operations team.
• Ensures that all aspects of electronic submissions meet regulatory agency and Halozyme’s submission standards and technical requirements.
• Expertise is required in the life cycle management of electronic submissions.
• Ensures that work instructions, check lists, and where necessary, SOPs, are written to document and streamline the work of the Regulatory Operations group.
• Responsible for the training of authors of eCTD documents in the organization. Ensures customization and update of templates and the development of a training program for the authors.
• Is responsible for the improvement and maintenance of the Regulatory Operations document management system.
• Plans development and implementation of records management policies intended to standardize filing, protecting, and retrieving records, reports, and regulatory submissions contained on paper and electronically.
• Assures compliance with policies, procedures, and practices of records management program.
• Applies expertise and experience to compile and release submissions to regulatory agencies during peak periods such as Investigational New Drug Applications (IND), New Drug Applications (NDA), IND/NDA supplements, IND/NDA Annual Reports, Periodic Safety Update Reports etc.

Required Experience

• BS/ BA/MS in a scientific discipline, information technology or business administration with 15+ years experience in the pharmaceutical or biotech industry and with a focus on Regulatory Operations
• Experience with eCTD and paper submissions with FDA
• International submission experience desirable
• Experience with document and electronic data management systems.
• Expertise in managing successfully a Regulatory Operations team
• Membership in an external Regulatory Operations working group desirable
• Individual with an attention to detail and highest quality standards
• Knowledge of GMP’s, GLP’s and GCP’s
• Excellent writing and verbal communication skills.
• Self-starter and team player
• Excellent problem solving skills
• Ability to multitask and work within a fast-paced dynamic team environment
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TECHNICAL KNOWLEDGE REQUIRED:

• Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required:
• Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Adobe, XML and SML authoring tools, ISI Toolbox, Octagon ViewPoint eCTD Software, Pilgrim Software, SAS file formats, Prizm, EDMS, Sharepoint

INTERNAL AND EXTERNAL RELATIONSHIPS:

• Reports to the Executive Director of Regulatory Affairs