Job Description

• The Sr.MgrRegulatoryOperationsis responsible for thecoordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impactof agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency

  • As an integral member of Otsuka’s regulatory operations team, providesregulatory publishing and submissionassignments, monitoring,andoversight, as well as alead orsupport for GRA efforts
  • Ensures assigned submissions are made with quality, on-time, and within established budgets
  • Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions
  • Liaise withaffiliatesfor coordinating and publishingdefinedcontent
  • Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as qualityand timelines are metin accordance withhealth authority requirements and Otsuka leadershipestablishedschedules
  • Designsand implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuousimprovements
  • Ensures submission and archival activities
  • Collaborates withalliance partners to achieve corporateobjectivesfor shared dossier development, submission, and archival activities
  • Supervises staff to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards
  • Oversees project team members for assigned submissions, including work assignments to vendor partners
  • Provides leadership and guidance for Process Mapping Teams (e.g, Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports)
  • Develops andmaintainsassigned regulatory operations work instructions
  • Establishes and builds collaborative relationships with colleagues
  • Responsible for organizing andmaintainingregulatory files
  • Providesregulatory publishing guidance to other departments functions

• Qualifications

  Required

  • Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions

  • Excellent knowledge and experience in regulatory operations,including:formatting, publishing,submitting,lifecycling, and archiving (eCTD) sequences

  • Demonstrated performance in managing and producing time-intensive deliverables

  • Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g.,DocuBridge,InSightPublisher,GlobalSubmitValidate,GlobalSubmitReview, andISIToolbox)

  • Strong computer skills withdemonstratedexperience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint

  • Knowledge in developing processes across multiple departments/divisions thatleveragetechnology

  • Recent experience with NDAs /MAAsis essential

  • Minimum of 7 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

  Preferred

  • Demonstrated performance in managing and producing quality time-intensive deliverables

  • Strong influencing skills and experience with outsourcing

  • Strongstaff management skills

  • Proven ability to solve complex issues through innovative problem solving

  • Well defined written and oral communication skills

  • Knowledgehow/when to apply organizational policy or procedures to a variety of situations

  • Demonstratedflexibility in dealing with change and diversity

  • Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment

  • Successful engagementin multiple initiatives simultaneously

  • Certification (such as Regulatory Affairs Professionals Society (RAPS))

  • Prior project management experience

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka

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