Senior Manager Regulatory Affairs

2 weeks ago

Santa Ana, United States PrimeGen US Full time

PrimeGen US Inc.

2917 Daimler Street,

Santa Ana, California 92705


Company Description

PrimeGen US is a pioneering biotechnology company dedicated to advancing stem cell research and developing groundbreaking cell therapies. We’re translating innovative discoveries into clinical solutions for acute and chronic inflammatory diseases. Our proprietary stemXcell platform leads the field in treating chronic and acute liver diseases, with FDA-authorized clinical trials on the horizon. In addition, we are actively pursuing preclinical and clinical studies for conditions like NASH and ASH while broadening our research into other inflammatory diseases. The Senior Manager of Regulatory Affairs will play a key role in bringing these transformative therapies to patients.



Position: Senior Manager, Regulatory Affairs

The Senior Manager of Regulatory Affairs will develop and lead regulatory strategies to ensure compliance with the U.S. FDA and international regulatory bodies. This role includes overseeing regulatory milestones from early research through clinical development and registration. The position requires managing regulatory submissions in both U.S. and global markets while working collaboratively with non-clinical, manufacturing, technical operations, clinical development, and CRO teams. As a strategic leader, you’ll guide cross-functional teams and support interactions with global health authorities and corporate partners.



Qualifications

  • Education: Bachelor’s or Master’s degree in a scientific field (advanced degree such as PhD, PharmD, or MD is a plus)
  • Experience: 5–10 years in the pharmaceutical or biopharmaceutical industry, with 3–5 years in regulatory affairs and strategy (cell therapy experience preferred)
  • Product Launches: 2–3 years of experience with cell therapy product launches preferred
  • Skills: Strong verbal, written, and interpersonal communication; demonstrated ability to manage projects independently; effective cross-functional teamwork
  • Expertise: Comprehensive understanding of regulatory processes and drug development, with proven adaptability in a dynamic, fast-paced environment


Key Responsibilities

  • Oversee the preparation, review, and submission of regulatory documents, including INDs, amendments, BLAs, supplements, annual reports, and safety reports
  • Lead regulatory submission meetings, including pre-IND and IND kick-offs
  • Critically assess complex technical documents and provide strategic feedback to cross-functional teams
  • Update project and study teams, as well as senior management, on regulatory progress
  • Coordinate responses to inquiries from CROs and regulatory agencies, including the FDA
  • Plan and execute regulatory submissions, fostering collaboration across departments
  • Offer regulatory guidance for ongoing and new initiatives aligned with company goals
  • Ensure timely compilation of required documents for regulatory submissions
  • Facilitate cross-functional alignment on regulatory strategies


PrimeGen US is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.


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