The Opportunity: Director, Regulatory Affairs Operations
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. Our team in San Diego is growing and we are seeking clinical operations professionals who want to be part of team dedicated to improving patient lives through the development of transformational medicines.
The Director, Regulatory Operations is an experienced leader accountable for supporting global regulatory objectives for the company’s development programs. The position serves as the company knowledge leader for compliance with submission requirements in the major regions for clinical trial and marketing applications. The position is responsible for business-side project management, business analytics, budgeting, and resourcing.
What you’ll dive into:
- Leads marketing application submission teams to develop and deliver applications in multiple regions (eg, US, EU, Canada, Australia) across all programs and indications.
- Brings and maintains expert knowledge on requirements for regulatory submissions, health authority briefing documents, and response documents.
- Brings and maintains expert knowledge of electronic submission and validation standards.
- Collaborates with Global Regulatory Leads and contributing departments to staff, plan and execute global regulatory submissions.
- Responsible for identifying potential risks to submission plans and developing risk mitigation strategies.
- Responsible for developing Regulatory Operations budgets and forecasting resource needs.
- Responsible for Regulatory Operations business analytics development and reporting as well as responsive process improvements to increase efficiencies.
- Accountable for overseeing the regulatory submission teams responsible for planning, creating, and submitting original US INDs and amendments, original US NDAs and supplements, EU MAAs and variations, Canadian NDS’s and variations in eCTD format, as well as ex-US clinical trial applications, as required.
- Expert knowledge of computerized system validation standards with accountability for system implementation and maintenance in accordance with company SOPs and applicable regulations.
What we expect:
- Experience driving content plan development for marketing applications in multiple regions (eg, US, EU, Canada, Australia).
- Bachelor’s degree in a related field required; advanced degree preferred.
- Minimum of 10 years of relevant and progressive experience in Regulatory Operations required.
- Fluent in eCTD standards with experience providing leadership and oversight to groups preparing and submitting through FDA eSG and EudraLink.
- Experience providing guidance during submission planning by applying knowledge of FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications.
- Ability to apply past experience to develop and propose submission risk mitigation plans.
- Experience creating and managing budgets, developing and reporting on business analytics, and creating process improvements for a Regulatory Operations function within Regulatory Affairs.
- Experience implementing, validating, and maintaining an EDMS Regulatory Information Management system.
- Strong communication skills with demonstrated ability to present and articulate requirements.
- Ability to work through others to attain goals.
- Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint, Smartsheets, and Veeva RIM.
- Ability to independently problem solve and offer solutions to functional leaders and collaborators.
- Demonstrated attention to detail, strong project management skills and ability to work in a fast-paced environment.
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 ($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 firstname.lastname@example.org.
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