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.
Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Manager - Advertising & Promotional Material (Ad/Promo) Review reviews materials for compliance with the regulatory requirements, monitors and analyzes issues in various phases of interactions with regulatory agencies and identifies trends important to the organization for use by management in decision making. The manager is also responsible for filing necessary regulatory submissions and handling all government interactions pertaining to Advertising & Promotional Materials.
Primary Duties and Responsibilities
Responsible for regulatory review of all advertising and promotional materials, including product labeling and press releases.
Responsible for filing necessary regulatory submissions and handling all regulatory agency interactions pertaining to Ad/Promo regulations for products requiring regulatory review/approval.
Supports processes by which regulatory notifications are reviewed, finalized, and signed-off.
Supports clinical to commercial product notification activities, as directed.
Provides analysis and background material in responses to regulations, policies, and legislation.
Participates in the development of organizational strategy to address regulatory affairs.
Assists in developing procedures to ensure regulatory compliance.
Manages and tracks queries, comments and commitments with regulatory agencies and provides periodic status updates regarding unfulfilled conditions/commitments.
Other duties as assigned
Advanced degree in the biological or food/pharmaceutical or regulatory sciences preferred.
8 - 12 years of relevant regulated industry experience, and at least 3 years’ experience in Advertising & Promotional Material Review is required.
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 regulatory agency notifications in the US and other countries 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/or Remote. 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.
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 product laws (Food/Infant Formula)
Notification/Submission/registration types and requirements, US, EU and ROW
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling.
Research and locate information on regulatory requirements and products
Handle detailed tasks and prioritize them to 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.
Positively impacting infants and your career
At Prolacta, we’re passionate about the work we do to improve infants’ well-being. Many of our employees have dedicated their careers to neonatal care, and more than 70,000 premature infants have benefited from our products.1 We succeed together knowing that the work we do makes a real difference—not only to the fragile infants we serve, but also to the families who love them.
Prolacta is committed to our employees, which is why we provide outstanding compensation and benefits, including:
Healthcare: Up to 100% medical/dental/vision insurance for employees and their families
Compensation: Competitive, performance-based raises and bonuses; discretionary stock options for all employees; 401(k) company match
Work/Life Balance: Four weeks PTO at year 1; generous time off program for new parents; flexible work schedules; reserved parking for expectant moms; electric vehicle charging stations on site
Professional Development: We’re committed to helping our employees thrive with educational opportunities and leadership programs such as our Women’s Leadership Development Academy and Educational Assistance Program
Community Engagement:... Company-sponsored community service opportunities for our employees and paid time off to volunteer at your child’s school or at other community organizations