Regulatory Assistant

Arena Pharmaceuticals San Diego , CA 92140

Posted 2 months ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

The Regulatory Assistant will work collaboratively with global regulatory program leads by engaging in activities supporting development programs as well as functional objectives and initiatives. Assignments will be based on demand and relative timing of needed deliverables requiring significant regulatory support. Examples of program-specific activities include submission planning and management, labeling development, advertising and promotional material review, regulatory intelligence, due diligence assignments, and pediatric study planning. Examples of regulatory functional activities include management support of health authority communications, meetings and interactions.

What you'll dive into

  • Support delivery of regulatory activities and documents associated with IND and clinical trial authorization applications, health authority meetings, and pediatric study plans

  • Assist in the development of draft target product labels and regulatory elements of integrated product plans for programs in development

  • Assist in review of program-specific medical communications and material supporting advertising and promotion of commercial products

  • Identify and assemble information on regulatory precedence to inform risks associated with proposed tactics, through review of regulations, guidance documents, advisory committee meeting minutes, previous approvals and previous submissions

  • Assist in development of correspondence with health authorities

  • Review documentation for submissions to ensure accuracy and clarity

  • Support due diligence of regulatory correspondence associated with assets undergoing business development evaluation

What we expect

  • BS/BA plus 5 years of relevant and progressive experience; PharmD or PhD with limited experience will be considered

  • Recent experience in reviewing regulatory documents such as Clinical Study Reports, Protocols, Summaries and Overviews

  • Recent experience in working with health authorities

  • Significant experience using Microsoft Office Suite including Word, Excel, Power Point and Outlook

  • Experience working within a cloud-based EDMS is preferred

  • Demonstrated ability to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines

  • Detail-oriented with effective problem-solving and troubleshooting skills

  • Excellent communication (verbal/written/presentation) and English skills required

  • Process oriented with the ability to understand complex data and information

  • Passion for science

What you'll get

  • 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

  • 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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Regulatory Assistant

Arena Pharmaceuticals