Manager, Regulatory Affairs

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 team, which is seeking a passionate individual, to fill the role of our Manager, Regulatory Affairs. This role will provide regulatory guidance to project development teams and is responsible for coordination and assembly of regulatory documents for review and submission to FDA in support of a clinical development program for new pharmaceutical products. This role is also responsible for providing advice on the strategy for the clinical development program, and for filing necessary submissions to FDA, including IND and IND amendments, and for handling all FDA interactions. This position will support regulatory activities throughout the product lifecycle, including Drug CMC development, post-approval changes, annual reports, and lifecycle management activities. It will also provide regulatory guidance for PMDA and other global regulatory authorities. 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 with the following duties and responsibilities… Coordinates and assembles regulatory and clinical documents for review and submission to FDA in support of a clinical development program. Provides advice in regards to the regulatory strategy for the clinical development program. Responsible for filing IND applications and IND amendments, and for handling all interactions with the FDA. Participates in the development of organizational strategy to address regulatory affairs. Coordinates preparation and review of CMC documentation supporting INDs, NDAs, amendments, annual reports, and agency responses. Develops and executes regulatory CMC strategies for investigational and commercial pharmaceutical products. Responsible for the following areas of Pharmacovigilance (PV); Global Safety Database and data analysis, signal detection, continual risk assessment of products and label conformance based upon PV data. Responsible for communicating medical complaint information to the market authorization holder in Japan (and other countries as applicable) in accordance with regulatory reporting timelines. Responsible for annual Periodic Safety Update Reports for Prolacta’s products. Responsible for performing the Annual Product Review for Drug Product requirements in Japan and other countries as applicable. Monitors evolving FDA, PMDA, ICH, and PIC/S requirements and communicates regulatory impacts to stakeholders. Develops regulatory procedures to ensure regulatory compliance. Manages and tracks queries, comments and commitments with FDA and provides periodic status updates regarding unfulfilled conditions/commitments. What You Bring To The Role Drug CMC requirements, CTD/eCTD submissions, ICH guidelines, PIC/S GMP expectations, and PMDA/MHLW pharmaceutical regulations 21 CFR Part 210 and Part 211 requirements for pharmaceutical products Qualifications Bachelor's degree in biological sciences, health sciences, pharmaceutical sciences, regulatory sciences, or a related scientific discipline is required. Advanced degree (M.S., Pharm.D., Ph.D., or equivalent) is preferred. 8+ years of progressive Regulatory Affairs experience in pharmaceutical, anti-infective, biologic, medical device, or combination product development, with expert knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents. 8+ years of relevant FDA regulated industry experience. Experience working at the FDA is highly preferred 5+ years of experience leading or overseeing U.S. regulatory submissions, including INDs, amendments, annual reports, meeting requests/packages, and other clinical development submissions. Experience with filing of IND submissions and supporting NDA submissions, including clinical trials in Phase I/II, for a pharmaceutical product is required Experience with anti-infectives and interacting with the Division of Anti-Infective Products at CDER is highly preferred Advanced knowledge of U.S. and global regulatory agency structures, review processes, and regulatory decision-making frameworks, including experience leading interactions with regulatory authorities and managing regulatory strategies. Expert understanding of the regulatory requirements governing pharmaceutical product development, including clinical, nonclinical, CMC, labeling, and lifecycle management activities. Knowledgeable of FDA Clinical Trial Guidance’s and regulations, pharmaceutical development process, and industry standard practices. Experience using electronic document management systems and document review tools desirable. Knowledge of technical alternatives and their potential effects on product quality, compliance, manufacturing processes, and business performance. Advanced knowledge of GxP regulations, including GCP, GLP, and GMP requirements, with demonstrated experience applying regulatory and quality system requirements across product development and commercial activities. Advanced technical writing and document review skills, with demonstrated experience authoring, reviewing, and approving complex regulatory submissions and regulatory correspondence. Demonstrated ability to research, interpret, and apply evolving regulatory requirements, guidance documents, and industry standards, and translate regulatory expectations into actionable business recommendations. Proven leadership and project management experience, including the ability to influence cross-functional teams and drive regulatory strategy across multiple programs. 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 your first day, to discretionary stock options 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: Duarte, CA (occasional travel to City of Industry office) Schedule: Monday – Friday, 8am to 5pm PST Travel: 10% FLSA: Exempt Candidates for positions with Prolacta Bioscience must be legally authorized to work for any employer in the United States. Verification of employment eligibility will be required at the time of hire. Prolacta Bioscience does not sponsor or takeover sponsorship of employment visas. 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. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. 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.