Regulatory Affairs Specialist II - Ad/Promo

Prolacta Bioscience; Duarte (CA); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work

Healthcare coverage

401(k) match

4 weeks PTO

Parental leave options

Job summary

Prolacta Bioscience is seeking a Regulatory Affairs Specialist II - Advertising, Promotion & Labeling to provide regulatory judgment on external-facing materials. Location allows remote work with travel onsite as needed, with a focus on advertising, labeling, and claims substantiation.

A bachelor’s in life sciences is required, with 7+ years in regulatory affairs across biopharma or similar regulated health products.

Qualifications

• Bachelor's degree in scientific/regulatory health fields required; advanced degree preferred.
• 7+ years of regulatory affairs experience in biopharma/pharma/medical device or similar regulated health products.
• Strong knowledge of FDA/FTC advertising, labeling, and promo requirements.

Responsibilities

• Provide regulatory perspective in cross-functional review of advertising, promotional, labeling, and other external-facing materials.
• Assess claims, substantiation, and labeling for compliance with regulatory requirements.
• Recommend compliant alternatives and document regulatory rationale.
• Support end-to-end material development, review, approval, and archival processes.
• Prepare or support regulatory submissions/dossiers for advertising/promotional materials and labeling.
• Monitor regulations and enforcement trends and communicate implications.

Skills

Regulatory expertise

Advertising review

Labeling compliance

Risk mitigation

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Regulatory certification preferred

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 Regulatory Department which is seeking a passionate individual, to fill the role of Regulatory Affairs Specialist II - Advertising, Promotion & Labeling.

The Regulatory Affairs Specialist II - Ad/Promo provides experienced regulatory expertise and perspective within the development, review, and approval process for advertising, promotional, labeling, packaging, digital, scientific, educational, and other external-facing materials. This role applies independent regulatory judgment to assess claims, messaging, artwork, references, intended use, substantiation, and labeling content for compliance with applicable requirements and alignment with approved source documents. The role provides clear regulatory rationale, identifies unsupported or non-compliant claims or messaging as appropriate, recommends practical compliant alternatives, identifies risks and escalation needs, and contributes to process improvement within assigned scope and delegated authority.

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…

• Provides experienced regulatory perspective in cross-functional review of advertising, promotional, labeling, packaging, digital, scientific, educational, technical, sales support, training, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
• Apply independent regulatory judgment within assigned scope to assess claims, benefit statements, graphics, references, DISCLAIMERS?, comparative language, product positioning, intended use, labeling implications, substantiation, and notification or submission need.
• Identify and address unsupported, misleading, or non-compliant claims or messaging; provide clear regulatory rationale, practical compliant alternatives, and defensible recommendations using a risk-based approach.
• Facilitate challenging review discussions professionally, support resolution of conflicting stakeholder feedback, and influence cross-functional partners toward compliant and business-practical outcomes.
• Support the end-to-end material development, review, approval, release, closeout, and archival process, including review records, claim support, references, final approved materials, and applicable regulatory notifications or submissions.
• Participate in cross-functional review activities; provide timely input on regulatory risks, tradeoffs, claim support, documentation needs, routine issue resolution, escalation needs, and recommended actions.
• Develop and maintain claim matrices, labeling references, checklists, templates, controlled documents, trackers, training tools, and review standards to support consistent regulatory execution.
• Identify systemic issues, documentation gaps, compliance risks, training needs, workflow inefficiencies, and inspection-readiness gaps; recommend and support corrective, preventive, or continuous improvement actions.
• Prepare or support relevant regulatory submission or notification dossiers for advertising/promotional materials, labeling, claims, and health authority requests, including required content, regulatory rationale, claim support, references, approvals, supporting records, and applicable system documentation.
• Monitor applicable regulations, guidance, enforcement trends, competitor practices, and industry standards, and internal learnings; summarize implications and recommendations for review.
• Support audits, inspections, and health authority requests related to advertising/promotional materials, labeling, claims, notifications, and supporting documentation.
• Provide technical input, peer review, and knowledge sharing.
• Perform other activities as assigned.

What you bring to the role

• Bachelor's degree in a scientific, regulatory, health sciences, nutrition, life sciences, or related field required; advanced degree or regulatory certification preferred.
• 7+ years of relevant Regulatory Affairs experience in biopharma, pharmaceutical, medical device, or similarly regulated health product industries, with substantial experience in advertising/promotional review, labeling, product claims, regulatory notifications, submissions, controlled documentation, or quality/regulatory compliance.
• Regulatory knowledge of advertising, promotion, labeling, product claims, intended use, claims substantiation, non-misleading communication, disclosure expectations, and applicable domestic and international regulatory requirements.
• Strong understanding of FDA, FTC, and other applicable regulatory requirements and guidance, including labeling, infant formula or health product communications, advertising substantiation, and promotional material notification or submission expectations.
• Demonstrated experience developing regulatory recommendations on complex commercial, scientific, technical, or customer-facing materials, including regulatory impact, claim support, labeling changes, notification needs, documentation requirements, and compliance risk mitigation.
• Proven ability to support cross-functional review processes, influence stakeholders without direct authority, resolve or upscale diverse comments, manage trackers, prepare status updates, and support timely completion of review, approval, submission, and record-retention activities.
• Ability to interpret scientific, technical, quality, manufacturing, operations, and product information to identify support concerns, documentation gaps, regulatory risks, escalation needs, and practical mitigation options in ambiguous situations.
• Experience with electronic document management, regulatory information management, promotional review, labeling, submission tracking, or document review systems required or strongly preferred, depending on business need.

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: Remote with availability to travel onsite as needed

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 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.

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