Senior Principal Regulatory Affairs Specialist myTOD Irvine, CA Job Details Full-time $170,000 - $200,000 a year 10 hours ago Benefits Health insurance Qualifications Biotechnology Medical writing Teamwork CCRP Data collection Full Job Description Overview We are seeking a highly experienced and dynamic Senior Principal Regulatory Affairs Specialist to lead and oversee complex regulatory strategies within the biotechnology and pharmaceutical sectors. This pivotal role involves ensuring compliance with global health regulations, managing regulatory submissions, and collaborating across cross-functional teams to facilitate clinical development and research initiatives. The ideal candidate will possess a deep understanding of FDA regulations, clinical research methods, and healthcare compliance standards, driving innovative solutions that support the advancement of biomedical products. Join us to contribute your expertise in regulatory affairs, clinical trials, and medical writing while shaping the future of healthcare innovation. Responsibilities Lead the preparation, review, and submission of regulatory documents for clinical trials, Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biological License Applications (BLA) in accordance with FDA regulations and international standards. Ensure compliance with pharmaceutical regulatory policies by staying current on evolving health regulation policies and integrating them into project strategies. Collaborate effectively with cross-functional teams including medical affairs, research, clinical development, and quality assurance to streamline regulatory processes and facilitate project milestones. Oversee data collection, analysis, and interpretation related to clinical research studies to support regulatory decisions and submissions. Develop technical writing materials tailored for researchers, regulatory bodies, and internal stakeholders that clearly communicate complex scientific data. Manage regulatory audits, inspections (including JCAHO standards for healthcare facilities), and ensure adherence to Good Clinical Practice (GCP) guidelines throughout clinical trials. Provide mentorship and leadership within the regulatory team to foster a culture of excellence in biomedical regulatory compliance and project management. Skills Extensive knowledge of FDA regulations, ICH GCP guidelines, healthcare compliance standards, and international health regulation policies. Proven experience in managing clinical research methods, clinical development processes, and regulatory submissions within a biotechnology or pharmaceutical environment. Strong data analysis skills with the ability to interpret complex datasets from clinical trials or health studies. Excellent technical writing skills for medical research documentation, regulatory reports, and scientific publications. Demonstrated team leadership abilities with experience managing cross-functional projects in a fast-paced setting. Familiarity with managed care systems, hospital experience (including Level I or Level II trauma centers), JCAHO standards, and biomedical regulatory compliance requirements. Effective communication skills for engaging with medical professionals, regulators, researchers, and internal teams to ensure seamless collaboration. Join us as a Senior Principal Regulatory Affairs Specialist to drive impactful healthcare innovations through expert regulatory management! Your expertise will be vital in navigating complex compliance landscapes while supporting groundbreaking clinical research efforts that improve patient outcomes worldwide.

Pay:

$170,000.00 - $200,000.00 per year

Experience:

professional regulatory: 9 years (Required) Ability to

Commute:

Irvine, CA 92603 (Required)

Work Location:

In person