Company

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.

Job Summary

Reporting to the VP of Quality and Regulatory Affairs, the Manager, Regulatory Affairs provides regulatory guidance to project development teams and is responsible for coordination and assembly of regulatory documents for review and submission to FDA in support of a clinical development program for new pharmaceutical products. The Manager, Regulatory Affairs is also responsible for providing advice on the strategy for the clinical development program, and for filing necessary submissions to FDA, including IND and IND amendments, and for handling all FDA interactions.

Primary Duties and Responsibilities

· Coordinates and assembles regulatory and clinical documents for review and submission to FDA in support of a clinical development program

· Provides advice in regards to the regulatory strategy for the clinical development program

· Responsible for filing IND applications and IND amendments, and for handling all interactions with the FDA.

· Participates in the development of organizational strategy to address regulatory affairs.

· Develops regulatory procedures to ensure regulatory compliance.

· Manages and tracks queries, comments and commitments with FDA and provides periodic status updates regarding unfulfilled conditions/commitments.

· 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 regulations for pharmaceutical/anti-infective product development

· Submission types and requirements in the US for clinical trials

· GxPs (GCPs, GLPs, GMPs)

· Ability 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

Qualifications

· Advanced degree in the biological, health, pharmaceutical or regulatory sciences preferred.

· 5-8 years of relevant FDA regulated industry experience, experience working at the FDA is highly preferred

· Experience with filing of IND submissions and supporting NDA submissions, including clinical trials in Phase I/II, for a pharmaceutical product is required

· Experience with anti-infectives and interacting with the Division of Anti-Infective Products at CDER is highly preferred

· Knowledgeable of FDA Clinical Trial Guidance’s and regulations, pharmaceutical development process, and industry standard practices.

· 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.

· 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.

Physical Requirements

a. Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

b. Physical requirements – Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday.

Direct Reports

N/A

Disclaimer

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.