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 Regulatory Affairs Specialist III monitors and analyzes issues in various phases of government regulatory procedures and identifies trends important to the organization for use by management in decision making. The Specialist III is also responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Primary Duties and Responsibilities
• Provides analysis and background material in responses to regulations, policies, and legislation.
• Participates in the development of organizational strategy to address regulatory affairs.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Assists in developing procedures to ensure regulatory compliance.
• 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 clinical to commercial product notification activities, as directed.
• 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 and creativity 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
• Advanced degree in the biological or food/pharmaceutical or regulatory sciences preferred.
• 5-8 years of relevant regulated industry experience including experience in regulatory affairs is required.
• 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.
• International experience with documentation and process of regulatory agency notifications is required.
• 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 10% 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.