Senior Manager/Associate Director Regulatory Strategy

Company: Takeda Pharmaceutical
Location: Florence
Posted on: November 24, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. - Join us as a Senior Manager/Associate Director Regulatory Strategy.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager/Associate Director Regulatory Strategy working on the Neuroscience Global Regulatory Affairs team, you will be responsible for complex or highly complex or multiple projects and lead the Global Regulatory Teams (GRTs) , and a typical day will include: -OBJECTIVES: -

• Oversees as well as executes all regulatory activities of multiple projects in development
• Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
• May serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility
• Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
• May be primary FDA contact for projects of responsibility.ACCOUNTABILITIES: -
  • Responsible for achieving submission of INDs, CTAs, NDA/BLA/MAA, briefing packages, responses, and other submissions..
  • Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule by local Takeda affiliates or development partners and CROs .
  • May develop/author or assist Global Regulatory Lead with development of global regulatory strategy.
  • For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy
  • Executes day-to-day activities for projects
  • Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
  • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
  • Assists and attends/.leads (when applicable) FDA and other agency meetings.
  • Leads regulatory reviews for licensing opportunities.
  • Participates in departmental and cross-functional task-forces and initiatives.
  • Identifies and notifies management of any resource gaps for project responsibility. - - -
  • Provides oversight to ensure regulatory compliance. -
  • Present to senior management as requested.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: -
    • BSc Degree preferred. -
    • A minimum of 4 years of pharmaceutical industry experience. - This is inclusive of 3 years of regulatory experience or combination of 4 years regulatory and/or related experience. -
      • Preferred experience in reviewing, authoring, or managing components of regulatory submissions. -
      • Working knowledge of drug development process and regulatory requirements.
      • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
      • Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
      • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
      • Must work well with others and within global teams. -
      • Able to bring working teams together for common objectives.LICENSES/CERTIFICATIONS:
        • None - -TRAVEL REQUIREMENTS:
          • Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required.
          • Requires approximately 10 % travel. -LOCATION:
            • The role can be hybrid (Cambridge) or remoteEEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Fayetteville , Senior Manager/Associate Director Regulatory Strategy, Executive , Florence, North Carolina