Prepares and submits electronic regulatory submission(s) according to applicable regulatory processes.
Prepares and submits FDA and EU regulatory submissions for opening of new plasma donation centers by due dates to ensure timely opening and licensing.
Monitors regulatory application due dates, prepares and submits changes to applications for new and renewed licenses, permits, and certificates for all facilities.
Maintains regulatory files in a manner consistent with regulations, policies and procedures.
Manages departmental employees including training, performance evaluation, career development, compensation administration and progressive discipline as needed according to company policies and procedures.
Develops and manage regulatory project plans.
Serves as Regulatory Affairs representative on project teams and provide regulatory guidance.
Serves as official FDA and EU correspondent.
Responds to regulatory agencies when required.
Coordinates the preparation and submission of Site Mater Files (SMF) to EU regulatory agencies.
Coordinates the preparations and submission of Plasma Master File (PMF) updates to customers.
Assists the Director, Regulatory Affairs in the coordination of EU audit preparation activities.
Reviews FDA, EU, IQPP, OSHA, CLIA and COLA regulatory changes for applicability and present applicable changes to the Regulatory Department for review.
Submits applicable regulatory changes to the Change Control Board for discussion and implementation.
Reviews draft SOPs for regulatory compliance.
Other job-related responsibilities as required.
Bachelor’s degree in life science or related field.
Five years’ experience in biologics, biotechnology or pharmaceutical industry with increasing regulatory responsibilities; or equivalent combination of education and experience.
Extensive knowledge of FDA and EU regulations and standards.
Strong written and verbal communication skills.
Plasma industry experience preferred.
Physical and Mental Working Conditions
Frequently performs work while sitting.
Frequently required to communicate and interact with employees and regulatory agencies.
For over 25 years, BPL has been a leader in the plasma industry. We are recognized both in the United States and in other countries for the consistently high quality of product we provide to pharmaceutical companies around the globe. BPL Plasma, Inc. is a subsidiary of Bio Products Laboratory Ltd, who manufactures a wide range of plasma products. Located in Elstree, near London (UK), we are commi...tted to research and development to maintain a key position in a constantly changing market in the 21st century.
BPL has 34 plasma centers throughout the United States. All of our plasma centers are FDA regulated and follow all industry guidelines. We pride ourselves on operating modern plasma facilities staffed with trained and friendly personnel.
In addition to collecting life-saving plasma, BPL compensates donors for their time, resulting in the infusion of thousands of dollars in to the local communities surrounding the centers. Moreover, BPL centers are involved in local area Chambers of Commerce and sponsor community activities such as neighborhood cleanups.