Manager, Regulatory Submissions Publishing

Takeda Pharmaceutical Medford, Massachusetts
manager regulatory regulatory submissions publishing publishing regulatory stakeholders management tools procedures health r&d patients
November 22, 2022
Takeda Pharmaceutical
Medford, Massachusetts
  • 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.
  • 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 Manager, Regulatory Submissions Publishing where you will support global processes; executing end-to-end submission assembly which includes publishing, quality control verification, finalization and delivery.
  • This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness.
  • You will assume the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers.
  • You will also take the lead in the development of administrative documentation, provide inter-departmental and/or external stakeholder mentoring, and play an integral role in the testing and implementation of new systems, tools, and processes.
  • As part of the Submissions Publishing, you will report to the Global Head Submissions Publishing and work with a variety of stakeholders.
  • Plans and manages detailed publishing timelines; provides reporting on publishing status to key stakeholders.
  • Proactively escalates publishing concerns, risks and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
  • Collaborates with other functional managers to develop strategies to mitigate risks to timelines and other issues
  • Keeps abreast of fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
  • When necessary and appropriate, steps in for or lends assistance to individual contributor direct reports to help drive results and achieve objectives.
  • Work closely with content providers to produce high quality submission-ready documents that adhere to internal and external electronic submission guidelines
  • Ensure submission documents meet the level of technical integrity required for Takeda publishing tools
  • Provide authors with formatting assistance as needed, as well as guidance with regards to publishing and referencing processes
  • Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions
  • Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
  • Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools
  • Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders
  • Identify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard procedures
  • Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
  • At least 6 years of experience in pharmaceutical/biotech industry, with 4 years of hands-on global regulatory submissions management and publishing experience.
  • Fully understands regulatory publishing and electronic document management systems
  • Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
  • Expert working experience of CTA s, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP and centralized procedures.
  • Including post marketing submissions such as variations, renewals, labeling etc.
  • Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
  • Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
  • 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
  • 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: $102,200 $146,000, 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 "remote" 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.
  • Massachusetts - Virtual

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