Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.
Reporting to the Director of Regulatory Affairs, the Specialist I will support day-to-day regulatory activities of assigned projects. These include support of preparation and compilation of submissions for regulatory agencies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.
Primary Duties and Responsibilities
· Manages and tracks queries, comments and commitments with regulatory agencies and provides periodic status updates regarding unfulfilled conditions/commitments.
· Supports processes by which regulatory notifications are reviewed, finalized, and signed-off.
· Supports commercial product notification activities, as directed.
· Manages tracking of regulatory notifications and approvals across all projects.
· Manages document archives and processes for regulatory documents.
· Transfers regulatory documentation into an electronic documentation system and ensures availability of regulatory information to other departments as needed.
· Identify and develop necessary standard operating procedures (SOPs) for Regulatory Affairs department to ensure regulatory compliance
· Participate in and support health authority/government agency inspections (e.g., FDA annual audits and health agency facility inspections)
· Lead interdepartmental alignment meetings to manage regulatory activities and strategize/plan for timely submissions
· Lead and collaborate with cross-functional teams to coordinate and implement regulatory submission strategies and content
· Create, maintain, and update templates for regulatory agency and health agency submissions
· Lead notification process for new and ongoing regulatory submissions, including planning regulatory strategy, compiling and evaluating data and information, authoring and routing draft notification documents with subject matter experts, preparing and submitting final notification, tracking and managing submission to closure, and maintaining submitted notifications for future reference.
· Review and recommend changes on proposed product labels/labeling, promotional material, other marketing documents, and operations/manufacturing changes to ensure the design/claims/process change/intended use are well supported and domestic/international regulations are met.
· Prepare, submit, and track required documents/forms for renewal of licenses and registrations for all company manufacturing facilities (e.g., tissue bank licensing and FDA food facility registration)
· Communicate with regulatory authorities on matters relating to compliance with applicable laws or regulations, pre-submission strategies, potential regulatory clarification, and/or follow-up on submissions under review
· Research regulatory issues and disseminate regulatory information to Marketing, Operations, Manufacturing, QA/QC, departments and senior management
· Other duties as assigned
Job Requirements and Qualifications
· Regulatory Knowledge (as applicable)
· Regulatory history, guidelines, policies, standards, practices, requirements and precedents
· Regulatory agency structure, processes and key personnel
· Principles and requirements of applicable product laws (Food/Infant Formula)
· Notification/Submission/registration types and requirements, US, EU and ROW
· GxPs (GCPs, GLPs, GMPs)
· Principles and requirements of promotion, advertising and labeling - Note: This knowledge may be developed through tenure in this position.
· Learn to write and edit technical documents
· Research and locate information on regulatory requirements and products
· Handle detailed tasks and prioritize them
· Meet deadlines
· Work with people from various disciplines and cultures
· Review and analyze documentation
· Exercise judgment within defined procedures and practices to determine appropriate action
· Develop general knowledge of technical alternatives and gain an understanding of their impact on associated products, systems and the business.
· Apply business ethical standards
· BA/BS degree in the biological or physical sciences preferred.
· Relevant regulated industry experience including experience in regulatory affairs preferred.
· Knowledgeable of Food and Infant Formula guidance’s, regulations, development process, and industry standard practices is desirable.
· Proficient in written, oral, and interpersonal communications in English.
· Ability to work in close collaboration with colleagues cross functionally.
· High attention to detail; ability to organize and prioritize assigned projects.
· Experience with documentation and process of FDA notifications is highly preferred.
· Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
Other Knowledge, Skills and Abilities
· Written and Verbal Communication Skills - Communication Skills or Ability to: Communicate effectively verbally and in writing
· Cognitive Skills - Ability to pay strong attention to detail
· Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Think analytically and critically
· Detailed oriented and strong organization skill
· Judgment and Decision Making
· Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate.
Work Environment (Location, travel, shift, on-call, etc.)
The position is located at the company offices in Duarte. The standard work hours are Monday through Friday, between 8 am and 5 pm. Occasional travel to the nearby manufacturing plant in City of Industry is required. This position may require out of town travel of less than 5% of annual work hours.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.