Director, Regulatory Operations-Remote応募後で応募 求人ID R0043403 掲載日 08/19/2021 Location:Boston, Massachusetts; Remote
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Regulatory Operations – Vaccines Business Unit in our Cambridge, Massachusetts office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Director, Regulatory Operations, Labelingand Compliance working in the Vaccines Business Unit team, you will be empowered to oversee the compilation and publishing of all regulatory submission types in accordance with Global Regulatory Affairs objectives for both marketed and developmental products, specifically global marketing applications and routine submissions e.g. lifecycle management and PSUR submissions. A typical day will include:
- Promote and advocate for a global e-working environment and drive efficient, standardized best practices for regulatory submission document management.
- Manage and prioritize publishing and administrative activities and ensure publishing strategies enable compliant dossiers to be delivered according to the worldwide regulatory submission plan and regional/country requirements.
- Define the strategic direction for electronic submissions and RIM in accordance with external evolving regulations and internal functional requirements.
- Engage with the Global Head and peers to define strategic vision and optimal interactions between the functional groups.
- Contribute to the evaluation, development and implementation of Regulatory Information Management Systems and efficient, harmonized processes to support regulatory activities including publishing, planning and tracking, document management and administration and archiving.
- Organize, lead and oversee the global publishing and submission processes to ensure the timely compilation, publication and distribution of valid electronic and/or paper submissions according to specific country requirements.
- Oversees technical aspects for submissions (e.g. eCTD granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, etc.)
- Manage team to provide expertise on requirements for regulatory submissions, health authority briefing documents and response documents.
- Serves as system owner for regulatory information tools and systems (e.g. eCTD publishing tools, electronic document management system (EDMS), library system and document templates).
- Ensure that Regulatory Information tools and systems are implemented, validated and maintained in accordance with company SOPs and applicable regulations.
- Maintain expert knowledge of electronic submission and computerized system validation standards.
- Manage tracking and timely archiving of regulatory submissions and communications.
- Partner with global peers as a thought leader in developing and redesigning harmonized, global submission compilation and build processes to maximize our ability to re-use submission components for multiple submissions and ultimately facilitate the delivery of global simultaneous submissions.
- Identify and assess risks that can impact submissions e.g. regulatory requirements, capabilities of internal tools, internal projects, etc and define strategies to mitigate those.
- Drive continuous process improvement through leadership of initiatives to capture learnings, identify opportunities for change and in partnership with global peers, develop a change management plan for implementation.
- Partner with peers to increase visibility of upcoming submissions and deliverables across the regions.
- Actively input to the overall vision for the evolution of technology and processes to support submission operations needs and evolving global electronic submission requirements. Participate in the definition of requirements and evaluation of technologies and support system implementation as appropriate.
- Assists with the development and implementation of standards for dossier management, publishing, archiving, metrics and submission process for global health authorities.
- Collaborates with the IT Business Partners to develop and provide training on RIM systems, tools and processes.
- Defines User Requirements for submission publishing, document management and archiving systems: e.g. EDMS and Tracking and Archiving systems and make recommendation for development / implementation.
- Manages the writing and/or review of Regulatory SOPs and Work Instructions.
- Oversee the publishing team with a strong emphasis on global team development, identity and continuity in regulatory submission and support services.
- Identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities.
- Manage, coach and ensure sustained performance of staff.
- Identify resourcing needs and appropriate allocation activities to internal and external support.
- Visionary leadership - drive continuous process improvements to enable an efficient and lean organization.
Maintain an expert, current knowledge of regulations, legislation, best practices and guidelines as they relate to global submission management and support and interpret into system or process changes as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• Bachelor’s degree, preferably in life sciences.
• 10 + years working within Regulatory and/or Regulatory Operations in the life sciences industry.
• 2 + years of experience of vendor/alliance management.
• Moderate first line management experience.
• Major document management and submission publishing experience.
• Proven experience in developing and implementing lean and efficient processes.
• Experienced in business change management.
• Fluent with the drug development process with evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes.
• Significant experience multitasking in a deadline controlled, complex and highly regulated environment.
• Experience introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation such as eCTD.
• Ability to apply knowledge to new situations. Strong communication skills. Demonstrated ability to present and articulate requirements and adjust to project needs.
This job posting excludes Colorado applicants.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
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
Empowering Our People to Shine
Learn more at takedajobs.com
Takeda 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.