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

 

The Regulatory Affairs Document Specialist is responsible for management of regulatory documents within the Regulatory Affairs Group. This includes requesting/retrieving of documents with regulatory relevance from all departments at Prolacta Bioscience as well as well as supporting these departments by supplying the required regulatory documents. The Regulatory Affairs Document Specialist may also be assigned to support specific day-to-day regulatory activities of the Regulatory Affairs Group.

 

Primary Duties and Responsibilities

 

·         Manages regulatory document storage (electronic and hardcopies) and the document archiving processes

·         Acts as a liaison between Regulatory and other departments to help obtain documents needed for regulatory submissions as well as respond to requests from other departments for regulatory documents and information.

·         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.

·         Manages tracking of regulatory notifications and approvals across all projects.

·         Transfers regulatory documentation into an electronic documentation system and ensures availability of regulatory information to other departments as needed.

·         Other duties as assigned

 

Job Requirements and Qualifications

 

·         Regulatory affairs knowledge (as applicable)

• Familiarity with Prolacta products, operations, strategy and industry trends

·         Basic knowledge of regulatory guidelines, policies, standards, practices, requirements and precedents

·         Basic knowledge of principles and requirements of applicable product laws (Food/Infant Formula)

·         Familiarity with notification/Submission/registration types and requirements, US, EU and ROW

·         Knowledge of GxPs (GCPs, GLPs, GMPs)

·         Learn to write and edit technical documents

·         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

·         Apply business ethical standards

 

Qualifications

 

·         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.

 

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.

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Stand		X
Walk		X
Sit				X
Talk or hear			X
Use hands to finger, handle or feel	X
Climb or balance	X
Stoop, Kneel, crouch or crawl	X
Reach with hands and arms		X
Taste or smell	X

 

c.     Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Up to 10 pounds		X
Up to 25 pounds	X
Up to 50 pounds	X
Up to 100 pounds	X
More than 100 pounds	X

 

 

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.