Regulatory Affairs Director - Global Regulatory Lead

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: April 13, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Regulatory Affairs Director - Global Regulatory LeadWhat you will doLet's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Director is to:

• Lead GRTs within Amgen's GRAAS organization,
• Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and
• Provide regulatory expertise and guidance to product teams.Key Responsibilities:
  • Develop and execute the global regulatory product strategy
  • Lead GRTs
  • Represent Regulatory on the product team and other key commercialization governance bodies
  • Develop Global Regulatory Strategic Plan and provide regulatory input into the products Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
  • Represent GRA on the product team
  • Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
  • Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
  • Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
  • Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
  • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
  • Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy
  • Communicate consistently well-defined, successful regulatory strategies throughout the organization such that expectation is understood
  • Ensure effective regulatory agency communications by leading core regulatory and cross-functional teams (e.g. GRTs, filing teams)
  • Attend key regulatory agency meetings which could impact the global product strategy
  • Represent Amgen Regulatory on external partnership teams at the product levelWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 4 years of regulatory experience in biotech or scienceOrMasters degree and 7 years of regulatory experience in biotech or scienceOrBachelors degree and 9 years of regulatory experience in biotech or sciencePreferred Qualifications:
    • Ability to lead and build effective teams
    • Strong communication skills - both oral and written
    • Ability to understand and communicate scientific/clinical information
    • Ability to anticipate and mitigate against future strategic issues & uncertainties
    • Ability to resolve conflicts and develop a course of action
    • Cultural awareness and sensitivity to achieve global results
    • Planning and organizing abilities
    • Able to prioritize and manage multiple activities
    • Ability to make complex decisions and solve problems
    • Ability to deal with ambiguity
    • Negotiation skills
    • Global Regulatory Affairs experience
    • Biological product experience
    • Early and late-stage development experience
    • Due Diligence experienceWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
      • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
      • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
      • Stock-based long-term incentives
      • Award-winning time-off plans
      • Flexible work models, including remote and hybrid work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
        #J-18808-Ljbffr

Keywords: Initial Therapeutics, Inc., Washington DC , Regulatory Affairs Director - Global Regulatory Lead, Executive , Washington, DC