Overview
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 Sr. Regulatory Affairs Specialist - Ad/Promo.
The Sr. Regulatory Affairs Specialist - Ad/Promo plays an important role within Regulatory and throughout Prolacta Bioscience. This role provides experienced regulatory review and lifecycle support for assigned advertising, promotional, labeling, packaging, digital, scientific, educational, and other external-facing materials.
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](https://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…
- Review assigned advertising, promotional, labeling, packaging, digital, scientific, educational, technical, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
- Evaluate proposed claims, benefit statements, graphics, references, disclaimers, comparative language, product positioning, and labeling changes for substantiation, regulatory impact, notification requirements, and escalation needs.
- Provide clear regulatory comments, rationale, recommended revisions, and practical guidance to Marketing, Medical Affairs, Legal, Quality, Operations, Manufacturing, and other stakeholders.
- Prepare, coordinate, track, close out, and archive regulatory notifications, approvals, submissions, review records, claim support, references, and final approved materials in applicable systems.
- Coordinate assigned cross-functional review activities, consolidate comments, support resolution of routine issues, manage trackers and milestones, and provide status updates, risk summaries, and recommended next steps.
- Support improving claim matrices, maintain labeling references, review checklists, submission templates, controlled documents, trackers, and other tools supporting consistent AdProm, labeling, and notification execution.
- Monitor applicable regulations, guidance, enforcement trends, industry practices, and internal learnings; summarize relevant requirements, risks, and process implications for stakeholders.
- Support audits, inspections, and health authority requests related to advertising/promotional materials, labeling, claims, notifications, and supporting documentation.
- Identify recurring review issues, documentation gaps, compliance risks, training needs, and process improvement opportunities within assigned areas.
- Exercise sound independent judgment within established policies, procedures, and assigned scope; manage competing priorities and escalate complex or high-risk issues under management oversight.
- 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 preferred.
- A minimum of 6 years of Regulatory Affairs experience with exposure to advertising/promotional review, labeling, product claims, regulatory notifications, submissions, controlled documentation, or quality/regulatory compliance activities.
- Working knowledge of advertising, promotion, labeling, product claims, intended use, claims substantiation, non-misleading communication, and applicable domestic and international regulatory expectations.
- Familiarity with applicable FDA, FTC, and PMDA requirements and guidance, including relevant labeling, infant formula, health product advertising substantiation, and promotional material notification or submission expectations. EMA and SFDA knowledge preferred.
- Experience assessing regulatory impact, claim support, labeling changes, notification needs, documentation requirements, and compliance risks for commercial, scientific, technical, or customer-facing materials.
- Experience coordinating cross-functional reviews, resolving comments, maintaining trackers, preparing status updates, and supporting timely completion of review, approval, submission, and record-retention activities.
- Ability to review scientific, technical, quality, manufacturing, operations, and product information to identify support concerns, documentation gaps, regulatory risks, escalation needs, and practical mitigation options.
- Experience with electronic document management, regulatory information management, promotional review, labeling, submission tracking, or document review systems desirable.
- Strong written, verbal, interpersonal, organizational, prioritization, problem-solving, and Microsoft Office skills required.
- Pharmaceutical and/or biologics experience required.
Qualifications:
- Attention to Detail — reviews advertising, promotional, labeling, scientific, technical, and regulatory content for accuracy, consistency, substantiation, traceability, and audit readiness.
- Communication and Collaboration — provides clear comments, rationale, status updates, risk summaries, and practical recommendations while working effectively with Regulatory Affairs, Marketing, Medical/Scientific Affairs, Legal, Quality, Operations, Manufacturing, consultants, and submission support resources.
- Organization and Follow-Through — manages assigned review timelines, routing, trackers, commitments, action items, controlled records, and competing priorities with appropriate oversight.
- Analytical Thinking and Judgment — evaluates claim support, labeling requirements, source documentation, regulatory trends, and process data to identify risks, gaps, mitigation options, and escalation needs.
- Guidance and Continuous Improvement — supports stakeholder onboarding, training, documentation needs, workflow improvements, and process efficiencies within assigned areas.
- Dependability and Adaptability — reliable, accountable, timely, flexible, and effective in managing changing priorities, deadlines, and assigned review, documentation, notification, and improvement activities.
- Integrity — demonstrates honesty, objectivity, and sound ethical judgment in regulatory review and documentation practices.
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
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.
