Senior Manager, Regulatory Technology

Job Summary

Senior Manager, Senior Manager, Regulatory Technology will lead activities related to process harmonization / alignment, requirements definition, ideation, and use of technologies to fulfil GRA needs. This position will partner with key cross-functional stakeholders to define business needs with a focus on process, data, and systems based on evolving Health Authority Regulatory needs, regulations, and related guidance documents, as well as drive GRA innovation projects. Seeks to continuously innovate by research / regulatory intelligence to understand and communicate changes related to GRA and explore available opportunities to meet GRA strategy and deliverables. Ensures adherence to establish business standards within GRA and cross- functional stakeholders. Partners with IT, DNA and AIPI on all GRA systems and tool changes needed. Collaborates with Global and Regional development organizations, affiliates, and in-licensed partners to drive effective change management, adoption, and value realization of applicable investments in regulatory technologies and tools.

Job Description

• Business ownership of Otsuka’s GRA systems (e.g., submission-controlled documents, publishing, labeling, RIM) that serve as the solutions to meet GRA objectives.

• Manages cross- functional stakeholder and GRA team engagement to ensure planning, implementation, and appropriate use of processes and systems given a strong understanding of regulatory processes.

• Represents GRA for business case creation, business requirements collections and prioritization, joint system investment opportunities, process improvements, innovations, roadmaps, and change championship.

• Develops, communicates, and builds consensus for goals and programs that support team and company objectives.

• Leads the regulatory business teams for responsibilities related to required processes, use, analytical needs, and continuous process improvement initiatives.   

• Executes and oversees the regulatory business strategy, resources, and practices; including, but not limited to Health Authority interactions, submission authoring, and labeling.

• Represents GRA on corporate and initiative process, people, and technologies workgroups to provide inputs (e.g., evaluations, schedules, budgets, requirements) to achieve measurable business outcomes.

• Executes corporate objectives to educate stakeholders on GRA business processes, builds consensus for goals and programs, and shares opportunities and improvements.

• Benchmarks and evaluates the effectiveness of work processes, operational plans and schedules to achieve the agreed program objectives.

• Makes critical decisions that capitalize on opportunities for optimization and effect positive change.

• Represent GRA on corporate innovation project drives.

• Provides input to mid-to long-range plans to carry out objectives established by group management.

• Manages adherence to terms and expenditures related to GRA contracts.

• Educates internal and external stakeholders on relevant systems uses or gain alignment when processes vary.

• Gather regulatory intelligence and communicate information regarding current activities, trends and changes in the regulatory environment to key stakeholder to enable informed risk-taking.

• Provides advice and interpretation of relevant quality regulations and guidance to GRA team.

• Makes key decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.

• Contributes to needed GRA G-SOPs, working practices, and instructional guides.

• Communicates regularly with key firms to keep current on existing and emerging GRA services and capabilities.

• Liaises with other R&D, IT functions, and among the GRA leads to ensure appropriate use of relevant technologies, consistent and harmonized business processes, and joint development of creative solutions to meet business needs.

• Participates with key stakeholders and GRA management in the development and implementation of strategic business plans, decisions and recommendations including providing required support or leadership of assigned projects and initiatives.

• Partners with IT and represents business stakeholders in jointly developing applicable service levels, systems governance, and support plan.

• Supports or leads other GRA initiatives as assigned.

Qualifications

Required

• Minimum of 10 years of pharmaceutical industry experience.

• Minimum of 5 years of regulatory experience

• Minimum of 3 years of contract administration.

• Minimum of 3 years of international or global project/initiative experience.

• Demonstrated knowledge of business use of regulatory technologies, including Publishing, EDMS, Submission tools, regulatory information management (RIM), and Identification of Medicinal Product (IDMP), and related regulatory requirements.

• Working knowledge of pharmaceutical industry regulatory-related laws, regulations, and guidance.

• Solid understanding of the FDA, EMA, and Health Canada organizations, helpful to have knowledge of other health authorities (e.g., PMDA).

• Demonstrated knowledge of regulatory requirements as they relate to user requirements, business contributions to validation.

• Ability to manage and supervise others including managed service providers and vendors.

• Familiarity with Submissions, Labeling, CMC, medical writing, and promotional compliance components of GRA.

• Experience working with global multi-lingual teams

• Proficient use of Microsoft Office products suite

• Results oriented / Innovation: Maintains focus that yields and creative and effective outcomes. Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects.

• Communication skills: Effective in written, spoke and listening activities. Thoughts are conveyed in a clear, concise and timely manner. Must be able to effectively convey complex or difficult information. Listens carefully to understand various points of view and is easy to approach.

• Problem solving skills: Demonstrates the ability to anticipate and identify core problems, apply insightful analysis, and solve problems effectively. Must be willing to confront tough or difficult issues.

• Detail Oriented: Demonstrates ability to set and communicate audit goals and standards for Otsuka. Administratively sound in the running of the audit office and meeting Otsuka and industry requirements for reporting. Maintains good records, organized, and timely.

• Proactively seeks out and accepts accountability for new and difficult challenges in the field of responsibility.

• Demonstrates the ability to manage change. Maintains controls for outcomes even when confronted with changes or new direction. Understands that there are often no single right answers.

• Demonstrates a strong desire to accomplish and earn success. Instills a sense of team

Preferred

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

• Strong staff management skills

• Proven ability to solve complex issues through innovative problem solving

• Well defined written and oral communication skills

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

• Demonstrated flexibility in dealing with change and diversity

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

• Successful engagement in multiple initiatives simultaneously

• 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 $146,955.00 - Maximum $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. 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.

Disclaimer:  

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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