Burst Biologics is a globally acclaimed pharmaceutical research institute and tissue bank that services communities across the U.S. with innovative products. Founded in 2010, Burst is committed to discoveries for life-altering conditions.
Burst Biologics is looking for a Director of Regulatory Affairs and Quality Assurance who will be responsible for providing independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. He/She will lead and manage the submission of licenses and authorizations for the maintenance of existing products, national registrations, and dossiers. He/She will oversee conformance with applicable regulations in product development, content labeling and help to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. He/She will coordinate with scientists and pharmaceutical officials to plan drug trials, facilitate drug research and interpret and report data to regulatory agencies. He/She must ensure all products meet state and federal guidelines during their lifespan. He/She will apply for all necessary approvals and marketing permits from the FDA. The candidate will track, obtain and renew any required permits and licenses.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Following is a summary of the essential functions for this job. Other duties may be performed, both major and minor, which are not mentioned below. Specific activities may change from time to time.
Lead a company-wide Quality Assurance and Regulatory Affairs department to facilitate product development and commercialization
Manage a complete and comprehensive quality system to support development and contract manufacturing of Human Cellular Tissue/Products and Bio-Pharmaceutical products.
Develop organizational/product regulatory and quality assurance strategies.
Assure regulatory compliance and quality assurance functions required to develop accurate specifications and delivery of products.
Evaluate and control vendor qualification of goods and services.
Manage regulatory elements of development schedules, personnel, resources and continuous improvement efforts to achieve efficient product creation and effective transfer of manufacturing.
Prepare documentation and submissions for regulatory filings. Conduct on site audits of various vendors and host regulatory agency audits as needed
Provide company-wide education and guidance in quality / regulatory sciences
Serve as primary regulatory representative responsible for facilitating all regulatory agency interactions
Provide appropriate communication and guidance to management and other internal functional areas responsible for submitting required regulatory documentation
Responsible assisting in development, and preparation for market, new products as outlined on the Company product strategy plan
Oversight and management of the firm’s ISO 9001 quality management system
Preparing, approving and monitoring the implementation of key documents
Ensuring that specifications and test procedures for materials are in place
Review of training records to check if on-the-job and induction training is taking place according to the schedule
Ensuring that planned/unplanned changes or deviations are documented, reviewed and analyzed, and recommending studies, tests or validation activities to be performed
Logging and responding to customer complaints, supervising the investigation into the cause of issues, providing an investigation reports to customers
Initiating, documenting and investigating market returns, destruction of finished batches, and informing regulatory authorities about defects found after distribution
Training and leading the internal audit team for each department, interacting with auditors during external, internal and customer inspections, and intimating management of the observations
Reviewing and approving manufacturing records and QC testing data before any intermediate, API or finished batch is released, as well as periodic trending of this data
Initiating an OOS (out of specification) investigation and reviewing the QC test if any raw material, packaging, intermediate or stability sample does not meet established and approved specification during the latter
Qualifying and auditing calibration service providers for tests and calibrations not performed in-house, reviewing and preparing Quality and Technical agreements for other manufacturing sites
Burst Biologics is located in Boise, ID, and offers competitive pay, Health, Dental & Vision benefit packages, FSA, a Matching 401k plan, and more.
Bachelor’s degree or higher with 8 plus years of related work experience with 3-5 years of recent management background.
Experience with IND/BLA submissions.
Experience with ANDA submissions is a plus.
Must be familiar and have experience with ISO 9000 Series Quality Management Systems. Must have implementation of Quality/Regulatory along with Bio-Pharmaceutical product development and manufacturing experience. Strong leadership skills and experience.
Must be familiar with cGMP and Title 21 CFR sections applicable to HCT/Ps and Bio-Pharmaceuticals. Must be able to work across multiple, internal organizations with varying outputs.
Have the ability to motivate others.
Maintain excellent communication and relationships with other people to foster real team effort within the Company.
Must be well organized, able to work with deadlines and under pressure while maintaining a level disposition
Must be able to work on multi-level projects with emphasis on timely follow-up
Have the ability to delegate, follow-up and maintain a positive attitude
Internal Number: 9102
About Burst Biologics
Founded to make a real-world impact, Burst Biologics is passionate about improving patient lives through new research. Our team of scientists is committed to researching complex and innovative treatments using biologics rather than traditional small molecule pharmaceuticals.