Senior Director, Global Regulatory Lead

Company: Arena Pharmaceuticals
Location: San Diego
Posted on: February 22, 2021

Job Description:

Arena Pharmaceuticals --is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.-- The Senior Director, Global Regulatory Lead (GRL) leads the global clinical/regulatory strategy for a program in late-stage development and provides leadership support to the marketing application submissions team for the program. The role is responsible for development of the strategy and content for global dossiers and target product labeling, engaging and interacting with the FDA, overseeing and supporting US regulatory activities in collaboration with business partners, and overseeing submissions and approvals of US applications. This role facilitates collaboration between colleagues in San Diego, Boston, and Zug on regulatory processes. The incumbent will participate on global program teams and act as the primary RA contact for the business on the assigned program. What you'll dive into Regulatory Strategy:

• Support development of the intended clinical use of the product candidate and its target product profile
• Lead and inform in-depth team understanding of US registration requirements and data gaps; proactively identify regulatory risks ensuring globally aligned negotiation and mitigation strategies
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy input from the Regulatory International function; ensure alignment and consistency of responses to global health authority queries with strategy and product positioning
• Participate as a team member on the global program team; provide strategic input to the team to identify regulatory pathways to NDA approvability and mitigations to development risks; establish one regulatory voice for communication of regulatory strategy to key stakeholders
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, etc.; review and approve key regulatory documents including IBs, INDs, IMPDs, CTAs, RMPs, and Pediatric Plans
• Lead interactions with US regulatory consultants/advisors for strategic input, as needed
• Monitor US regulatory guidelines and trends, and communicate appropriately to key stakeholders Health Authority Interactions:
  • Lead all communications and meetings with FDA for the assigned program; lead and oversee preparation of FDA meeting materials
  • Support meetings with health authorities outside the US (OUS) in collaboration with the Regulatory International function, as applicable
  • Lead responses to questions from FDA on preclinical and clinical issues to ensure appropriate, consistent, and complete answers; ensure responses are aligned with global development strategy; contribute and review responses to questions from OUS health authorities
  • Establish and maintain a strong relationship with FDA project managers
  • Act as contact for FDA on quality and compliance matters; ensure adequate RA support during FDA inspections
  • Support compliance of TMF process with FDA regulations and guidance Submissions and Approvals:
    • Lead the US strategic submission planning process in collaboration with the global program team
    • Lead US IND and NDA submissions; deliver gap analysis and recommendations for optimized processes to enable successful submissions
    • Deliver an approvable NDA and Pediatric Study Plan (PSP)
    • Work closely with Regulatory Operations to support IND and NDA preparation, publishing, and submission Labeling:
      • Support identification and internal agreement of optimal product labeling; provide strategic input on Target Product Profile, CCDS and country-specific labels
      • Support and ensure generation of US product information that is aligned with global strategy
      • Collaborate with Regulatory Labeling to support and ensure effective and compliant US label generation and control processes, as applicable What we expect
        • BS or MS degree in a scientific discipline with minimum 10 years of regulatory and drug development experience across all phases (1-4); advanced degree (MD, PhD, PharmD) preferred
        • Fluency in English as a business language; additional language is an asset
        • Significant experience in a leadership role with NDA submissions and approvals; experience with MAA submission preferred
        • Experience in a leadership role with FDA negotiations
        • Experience with brand optimization strategies and commercial awareness
        • Demonstrated ability to analyze and interpret efficacy and safety data
        • Strong understanding of regulatory operational activities
        • Demonstrated proficiency in people management
        • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
        • Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global matrixed teams 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
          • 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 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 . By submitting a resume for consideration, applicants verify that they have read Arena's Applicant Personal Information Privacy Notice . Do you now, or will you in the future, need sponsorship from an employer in order to obtain, renew or extend your work authorization in the U.S.? --*
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Keywords: Arena Pharmaceuticals, San Diego , Senior Director, Global Regulatory Lead, Executive , San Diego, California