Agility Clinical, a Precision Medicine Group Company, is a unique consulting and contract research organization dedicated to helping virtual, small biopharma and device companies who are developing treatment for rare diseases - move forward and bring important new treatments to patients.
This executive level position is responsible for overseeing the Regulatory Affairs function in support of clients developing regulated products, for training of staff and for development of departmental processes in compliance with government regulations concerning investigational and approved products, ICH Guidelines, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs). This position involves strategic planning and communications with clients, regulatory authorities, and Agility personnel (employees and consultants).
This opportunity is based out of our Carlsbad, CA office
Maintain up-to-date knowledge of regulations, guidelines and pharmaceutical industry standards and practices with regard to regulated product development.
Responsible for authoring and/or reviewing SOPs for regulatory processes at Agility.
Ensure that project deliverables comply with applicable regulations, guidelines, SOPs, and/or client specific formats, as applicable.
Responsible for preparing or overseeing the preparation of documents for regulatory submission, e.g., regulatory meeting requests, Information Packages, INDs, IND amendments, Annual Reports, DSURs, PSURs, NDAs, ANDAs, and applications for Orphan Drug Designation, Fast Track Designation, Breakthrough Therapy Designation.
Prepare documents for electronic submissions.
Minimum of 12 years of combined industry, regulatory agency, and/or academic experience.
CRO experience or working knowledge of CRO operations highly desirable.
In-depth knowledge of GCPs, ICH guidelines and FDA regulations.
Knowledge of US and global requirements with regard to regulatory submission processes and content requirements. Direct experience with the preparation of documents for regulatory submission.
Regulatory Affairs certification advantageous, but not required.
Intermediate proficiency in Microsoft Word, Microsoft Excel, and PowerPoint.
Demonstrated ability to plan, execute, control and deliver.
Ability to read, analyze, and interpret common scientific and technical journals, to respond to common inquires or complaints from regulatory agencies; to effectively present information to top management, public groups, and/or board of directors.
Able to define problems, collect data, establish facts, and draw valid conclusions; to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract an concrete variables.
Ability to evaluate regulations and electronic processes and requirements.
Must possess a professional demeanor, a customer service demeanor; demonstrate keen attention to detail, effective organization and time management skills, and the ability to communicate effectively.
Must possess the ability to multitask and manage multiple and changing priorities with adherence to deadlines.
Agility Clinical is a unique consulting and contract research organization dedicated to working with virtual, small biopharma and device companies with a lean infrastructure. We put our expertise and passion to work helping small companies – particularly those involved with orphan drug development – to move forward and bring important new treatments to patients.
At Agility, we understand the s...pecial challenges that are part of drug and device development. With a senior management team that has extensive experience, we are here to provide our clients with sound advice and the best service possible.
We are here to help with program or protocol development, project management, biostatistics, data management, clinical operations, medical monitoring, safety case processing, and regulatory affairs.
You will get the best possible quality and customer service on every single project.