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Associate Director, GRA Regional Compliance - All regions

Company: Takeda Pharmaceutical
Location: Danielsville
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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as an Associate Director, GRA Regional Compliance - All regions where you will provide direction and leadership in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, within Regional and Local Operating Companies (LOCs), while meeting Takeda corporate objectives. Be responsible for overseeing across the regions/LOCs, updates and maintenance of systems linked to regulatory activities e.g., Regulatory Information Management System, including the timeliness, quality and accuracy of information. Oversees the implementation of GRA processes, systems and procedures for GxP processes (e.g. change control, deviations/CAPAs, etc.) across the Local Regulatory Affairs regions ensuring execution and compliance.You will also provide direction and oversight in the management of submissions and submission activities across the Local Regulatory Affairs regions in accordance with local regulations. Responsible for overseeing global regulatory compliance metrics at a country/regional level. Manage oversight of audits and inspections related to Regulatory affairs processes globally within Local Regulatory Affairs. Partner and provide direction with the Regulatory Area Heads on key Regulatory strategic initiatives and/or issues. Partner effectively with cross functional teams, in the proactive identification of key regulatory compliance issues to determine actionable project proposals and drives them to successful resolution. As part of the Global Regulatory Regional Compliance team, you will report to the Director, Global Regulatory Regional Compliance.How you will contribute:

  • Responsible for demonstrating Takeda leadership behaviors.
  • Lead critical GRA projects for GRA Compliance for both strategic and operational organization, compliance and effective implementation
  • Drives compliance within Local Regulatory Affairs linked to regulatory submissions including the updating and maintenance of systems used for regulatory activities
  • Monitors global regulatory compliance performance within Local Regulatory Affairs and takes action to address issues
  • Oversees the development, implementation and understanding of regional and local RA training materials related to global regulatory processes/systems. Delivers training as needed
  • Oversees the update and management of all regional/Local Information/access sites/portals/distributions; and facilitate creation, implementation and maintenance of communications and effective change management of RA processes in region/LOCs.
  • Oversees inspection and audit activities within Local Regulatory Affairs. Monitors trends and looks for opportunities to ensure audit and inspection readiness
  • Develop strong partnerships with cross functional leadership within the regions/LOCs.
  • Lead and engage in efforts to simplify and optimize business processes and platforms to drive growth and seeks opportunities for automation of manual processesMinimum Requirements/Qualifications:
    • Bachelor's Degree in a science or business-related field.
    • At least 8 years of experience in pharmaceutical industry, with 6 years in Regulatory Affairs, research and development, quality assurance/compliance
    • People management skills
    • Familiarity with Regulatory systems
    • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
    • Demonstrated knowledge of health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices in applicable regions.
    • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
    • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
    • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
    • Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
    • Willingness to travel to various meetings, including overnight trips.What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Base Salary Range: $143,500 - $205,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#RM-LIEEO 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, Allentown , Associate Director, GRA Regional Compliance - All regions, Executive , Danielsville, Pennsylvania

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