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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 . 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.? --*
              Address --*
              U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Arena Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
              • Autism
              • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
              • Blind or low vision
              • Cancer
              • Cardiovascular or heart disease
              • Celiac disease
              • Cerebral palsy
              • Deaf or hard of hearing
              • Depression or anxiety
              • Diabetes
              • Epilepsy
              • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
              • Intellectual disability
              • Missing limbs or partially missing limbs
              • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
              • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Arena Pharmaceuticals, San Diego , Senior Director, Global Regulatory Lead, Executive , San Diego, California

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