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Executive Director and Head, CMC Regulatory Affairs - Biologics

Company: Takeda Pharmaceutical
Location: Brooklyn
Posted on: November 20, 2023

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 and . 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 a Executive Director and Head, CMC Regulatory Affairs- Biologics where you will Leads the Biologics CMC regulatory team in the development and implementation of global CMC regulatory strategies for products throughout development and commercial lifecycle. As part of the GRA CMC- Biologics organization you will report to Head of Global Regulatory Affairs CMC & Medical DevicesHow you will contribute:

  • Responsible for demonstrating Takeda leadership behaviors. - Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. -
  • Provides leadership of GRA CMC Biologics regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
  • In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner
  • Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associtions, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
  • Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
  • Build and maintain communication strategy and platform for all staff across the organization. - - Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.
  • Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
  • Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
  • Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
  • Leads or plays a key role on the relevant internal Takeda governance committeesTechnical/Functional (Line) Expertise
    • Comprehensive understanding of the pharmaceutical industry with experience in regulatory filings across the lifecycle
    • Expert knowledge of biopharmaceutical CMC development, product registration and maintenance regulations with experience in championing innovation in technical areas.
    • Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure.
    • Knowledge and understanding of relevant emerging regulations and related processes
    • Knowledge of diverse therapeutic areas and recent innovative treatmentsLeadership
      • Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.
      • Ensures that every employee knows what is expected of their role and what it takes to be successful. - Helps employees grow through challenging assignments so they may realize their full potential.
      • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
      • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
      • Ability to distil complex issues and ideas down to simple comprehensible terms
      • Executive leadership presence and confidenceDecision-making and Autonomy
        • Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization
        • A member of Global CMC & devices Leadership team and an extended/ad-hoc member of the GLobale Regualtory Affairs Policy and Intelligence team
        • Ad-hoc participation in senior leadership teams as needed
        • Responsible for internal processes and systems to support external representation are implemented and effectively working.Interaction
          • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
          • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
          • Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner
          • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to GMS, GQ, Pharmaceutical sciences, clinical pharmacology and the therapeutic areas.Innovation
            • A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry
              • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
              • Comfortable challenging the status quo and bringing forward innovative solutions
              • Ability to take risks implementing innovative solutions, accelerating time to marketComplexity
                • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
                • Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlinesMinimum Requirements/Qualifications:
                  • Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
                  • Languages: Fluent in English (oral and written); additional languages desirable - - -
                  • Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
                  • Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
                  • Actively engaged in major industry associations (e.g. EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
                  • Strong communication, collaboration, negotiation, problem solving and interpersonal skills. - Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
                  • High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teamsWhat 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.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Preference will be given to candidates with a remote location near, and availability to work during the working hours of, the corporate office in Boston, Massachusetts.Base Salary Range: $$194,600 to $278,000, 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.The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.EEO 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, New York , Executive Director and Head, CMC Regulatory Affairs - Biologics, Executive , Brooklyn, New York

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