Manager, Regulatory Operations

Arena Pharmaceuticals - San Diego, CA (30+ days ago)3.9


The Opportunity
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Arena is a growing, fast-paced organization with a start-up mentality. This regulatory project management role will support tactical regulatory planning based on U.S. and global regulatory requirements. The successful candidate will coordinate and manage the compilation and assembly of regulatory documents included in submissions, in compliance with regulatory health authority regulations/guidelines and corporate policies/procedures within agreed timelines.

What you'll dive into
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  • Develop and implement tactics to facilitate internal processes resulting in final regulatory documents supporting the development of corporate assets throughout their lifecycle, including preclinical, Phases 1-3, and registration.
  • Lead, manage, and coordinate the content development process (planning, creation, review and approval) of regulatory documents included in submissions to health authorities.
  • Review technical reports and summary documents for submission to FDA and global health authorities (e.g. clinical protocols and study reports; investigator brochures, pharmacology, pharmacokinetic & toxicology reports) for adherence to regulatory guidelines, strategies, and commitments.
  • Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines.
  • Prepare data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs.
  • Author and review forms supporting information in INDs and Clinical Trial Applications submitted to European Union health authorities.
What we expect
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  • Bachelor's or Master's degree in a life science or relevant discipline
  • 5+ years of experience in a regulatory affairs function within the biopharmaceutical industry
  • Electronic document management system experience
  • Personal management and organizational skills; collaboration, communication & problem-solving
What you'll get
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  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.
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