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Associate Director, Regulatory Publishing and Submission Management

Company: Takeda Pharmaceutical
Location: Mahwah
Posted on: November 25, 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, innovation-driven company that will inspire you and empower you to shine?Join us as -a Associate Director, Regulatory Publishing and Submission Management. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES/PURPOSE: This key position is part of Global Regulatory Operation (GRO) and reports to the Director, Regulatory Publishing and Submission Management. - The Associate Director, Publishing and Submission Management will support both strategic and operational activities:

  • Provide project and publishing group leadership, and submission oversight in support of Takeda Pharmaceuticals products.
  • Collaborate with submission teams, to plan and execute timely regulatory submissions, primarily in eCTD/NeeS formats, in support of investigational and marketed products
  • Own submission plans to develop, track and report on deliverables for major milestone submissions including initial NDA, BLA, NDS, or MAA. Identify potential risks to submission plans and propose risk mitigation strategies.
  • Partner with project management and functional areas to develop strategic plans for health authority submissions and interactions.
  • Liaises with other functional managers to ensure consistency of departmental approach within the company.
  • Effectively forecast and manage project specific resources utilising flexible resourcing, and employing global load sharing as standard business practice
  • Recognize the internal and external interdependencies among submission activities that could have an impact to the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.ACCOUNTABILITIESThe Associate Director, Publishing and Submission Management will demonstrate Takeda leadership behaviors to accomplish the following responsibilities that include but are not limited to:You are a great fit for this opportunity if you are engaged and energized by:
    • Assists in building effective relationships with external publishing vendors/contractors and software providers as appropriate to facilitate effective processing of the regulatory submission workload.
    • Provides support in assuring adherence to budgets, schedules, work plans and key performance indicators (KPIs).
    • Assists in developing and maintaining operational strategies for improving Publishing systems/ processes for the efficient publishing and archiving of regulatory submissions
    • Maintains fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
    • Contributes to decisions making on administrative and operational matters and ensures the publishing team effectively achieves its objectives.
    • Maintains an expert, current knowledge of validated systems.
    • Represents the company at relevant industry forums and/or software user groups.
    • Collaborates with other departments to identify, investigate, and implement new business opportunities.
    • When necessary and appropriate, steps in for or lends assistance to direct and indirect reports to help drive results and achieve objectives.
    • Good knowledge of company people management policies and procedures including hiring, performance management, corrective action, and compensation administration
    • Good leadership skills including changes management, people development, strategic thinking and influencing
    • Ability to manage team resources to ensure attainment of department objectives.
    • Advanced knowledge of regulatory publishing and electronic document management systems
    • Excellent written and oral communication skills.
    • Ability to manage multiple customer interfaces and ensuring customer satisfaction
    • Effective skills in delivering/ overseeing/ evolving user facing publishing services
    • Ability to manage operational responsibilities across disciplines and multiple regions/countriesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -We would be thrilled if you brought the following with you:
      • 10 + years of experience in pharmaceutical/biotech industry, with 8+ years of hands-on global regulatory submissions management and publishing experience.
      • 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 managing individual contributors in addition to the ability to lead by influence and work effectively in matrix organizational structures
      • 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
      • Understanding of relationship management with demonstrated experience in partnering in large scale situations
      • Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.
      • Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model.
      • Must have proven track record to be able to think critically, strategically, independently and problem solve
      • Must have high level of motivation, drive, and demonstration of Takeda's leadership values
      • Excellent written and verbal communication skills
      • Top notch interpersonal skills in difficult situations
      • Ability to work seamlessly with all levels of personnel
      • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
      • Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skillsWHAT TAKEDA CAN OFFER YOUAt 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.Empowering Our People to ShineDiscover more at takedajobs.comAt our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? LocationsZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Paterson , Associate Director, Regulatory Publishing and Submission Management, Executive , Mahwah, New Jersey

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