Regulatory Affairs Specialist II

Prolacta Bioscience; Duarte (CA); Hybrid; USD 90,000 - 145,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) match

PTO (paid time off)

Parental leave

Employee affinity groups

Volunteer time off

Educational opportunities

Job summary

Prolacta Bioscience in City of Industry/Hybrid is seeking a Regulatory Affairs Specialist II to support regulatory submissions, registrations, renewals, and health authority interactions. You will manage dossiers and documentation, coordinate cross-functional input, and help ensure traceability and inspection readiness.

The role emphasizes applying regulatory requirements, maintaining compliance, and supporting lifecycle management in a fast-paced environment.

Qualifications

• Bachelor's degree in science, nutrition, food science, regulatory affairs, technical, or related discipline required; advanced degree or RAC certification preferred.
• Minimum of 3 years regulatory affairs or relevant regulated industry experience, preferably in biologics/pharmaceuticals, with exposure to submissions, registrations, lifecycle management, or regulatory operations.
• Working knowledge of FDA requirements, GMP principles, CMC concepts, and international regulatory frameworks.

Responsibilities

• Support submissions, registrations, renewals, amendments, and dossier maintenance activities; track timelines and deliverables.
• Develop, maintain, and provide supporting rationale for product dossiers, regulatory documentation, and licenses to support traceability and inspection readiness.
• Review regulatory documents for suitability, completeness, and impact on submissions and market maintenance.
• Coordinate cross-functional regulatory activities, obtain data, reconcile comments, and communicate status and risks.
• Draft routine health authority correspondence, meeting materials, and deficiency responses under supervision.
• Support internal audits, regulatory readiness activities, and periodic reviews within assigned scope.

Skills

Regulatory submissions

Regulatory operations

Documentation review

Cross-functional coordination

MS Office

Education

Bachelor's degree in science or related field

RAC certification preferred

Tools

Regulatory information management

Document management systems

MS Office

Job description

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our IT Department which is seeking a passionate individual, to fill the role of Regulatory Affairs Specialist II.

The Regulatory Affairs Specialist II provides regulatory execution support for assigned products, markets, and projects within defined scope and under appropriate management oversight. The role supports submissions, registrations, renewals, notifications, dossier maintenance, lifecycle management, regulatory operations, change assessments, and health authority correspondence by applying regulatory requirements, reviewing source documentation, coordinating cross-functional input, and preparing compliant documentation and recommendations. This position manages assigned deliverables, timelines, records, and documentation packages with focus on accuracy, completeness, traceability, and inspection readiness; identifies routine to moderately complex risks or gaps, supports mitigation activities, participates in assigned health authority interactions, provides practical regulatory support to stakeholders, and escalates complex or high-risk issues to management.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk- based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com

How you will contribute

This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by...

• Support assigned submissions, registrations, renewals, amendments, supplements, notifications, agency responses, and dossier maintenance activities; assess defined requirements, compile documentation, track timelines, and support deliverables through completion.
• Develop, compile, review, maintain, and provide supporting rationale for product dossiers, regulatory documentation packages, records, correspondence, approvals, licenses, registrations, certificates, commitments, decisions, and supporting evidence to support traceability, data integrity, and inspection readiness.
• Review scientific, technical, quality, manufacturing, CMC, clinical, labeling, operational, and product documents for regulatory suitability, completeness, consistency, traceability, and potential submission or market maintenance impact within assigned scope.
• Apply applicable regulations, guidance, health authority expectations, industry standards, internal procedures, and prior approvals to support submission planning, change assessments, correspondence, dossier decisions, and recommended actions.
• Coordinate assigned cross-functional regulatory activities, obtain required data, reconcile comments, address routine documentation issues, maintain trackers and timelines, communicate status and risks, and support mitigation actions.
• Support regulatory assessments of product, process, manufacturing, supplier, specification, labeling, and operational changes to determine potential submission, notification, registration, dossier update, health authority communication, or market maintenance requirements.
• Draft and revise routine health authority correspondence, meeting materials, response narratives, data summaries, justifications, deficiency responses, and supporting documentation; support assigned agency queries, clarification requests, and follow-up activities under management oversight.
• Support internal audits, external inspections, regulatory readiness activities, and periodic reviews by evaluating dossier completeness, confirming record traceability, preparing evidence packages, and responding to information requests within assigned scope.
• Support development and improvement of regulatory templates, submission checklists, dossier tools, controlled documents, work instructions, trackers, and operational processes.
• Monitor applicable regulations, guidance, standards, enforcement trends, health authority expectations, agency feedback, submission outcomes, commitments, and internal learnings; analyze trends to identify potential risks, recurring issues, and improvement opportunities, and summarize findings for management review and evaluation.
• Provide practical regulatory support to peers and cross-functional stakeholders on applicable requirements, documentation standards, submission expectations, and lifecycle maintenance practices within assigned scope.
• Exercise judgment within defined policies and procedures on assigned regulatory matters; manage competing priorities, recommend practical actions, and escalat...
• Contribute to team development by sharing knowledge, participating in process improvements, and supporting consistent application of regulatory procedures and documentation practices within assigned scope.
• Other duties as assigned.

What you bring to the role

• Bachelor's degree in science, nutrition, food science, regulatory affairs, technical, or related discipline required; advanced degree or RAC certification preferred.
• A minimum of 3 years of Regulatory Affairs or relevant regulated industry experience, preferably in biologics, biopharmaceutical, pharmaceutical, infant formula, nutrition, medical product, or similarly regulated environment, with exposure to submissions, registrations, product dossiers, renewals, notifications, health authority correspondence, lifecycle management, controlled documentation, or regulatory operations.
• Working ability to apply regulatory requirements and health authority expectations, evaluate source documentation, identify routine regulatory risks or gaps, and recommend practical actions for assigned projects, changes, products, or markets.
• Working knowledge of FDA requirements, food/infant formula and/or drug regulations, GMP principles, CMC documentation concepts, domestic and/or international regulatory frameworks, and submission, registration, lifecycle, change assessment, health authority response, and record-retention processes.
• Experience reviewing scientific, technical, quality, manufacturing, CMC, clinical, labeling, operational, and product documentation to support regulatory submissions, impact assessments, rationale, mitigation recommendations, and inspection-ready records.
• Experience coordinating assigned cross-functional submission or regulatory operations activities, resolving routine documentation issues, communicating status and risks, and tracking deliverables to completion.
• Experience with electronic document management, regulatory information management, submission tracking, document review, or controlled records systems desirable.
• Experience supporting health authority responses, agency meeting materials, regulatory justifications, technical summaries, submission-ready narratives, inspection/audit evidence packages, international registrations, CMC regulatory activities, biologics/pharmaceutical products, or deficiency responses preferred.
• Strong written, verbal, interpersonal, organizational, prioritization, problem-solving, technical writing, analytical judgment, and Microsoft Office skills required.

How Prolacta benefits you

To drive the personal growth and business impact of our employees, we're committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on the first day of the month after your first day and 401(k) match, we value our employees' health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What else do you need to know

Location: City of Industry/Hybrid

Schedule: Day shift

Travel: 10%

FLSA: Exempt

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. Employee will frequently lift and/or move up to 10 pounds.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

"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.