The Regulatory Technologies Solutions Associate Director represents Global Regulatory Affairs as the business owner of Regulatory systems. Acts as the Regulatory point of contact for the development, implementation and governance of the GRA systems roadmap. Ensures GRA systems roadmap strategy is aligned with and will effectively support GRA vision/strategy and liaises with external partners to ensure the vision is realized.
Represents the business needs related to technology, systems and Regulatory Information Management on GRA initiatives, to ensure the teams meet their goals and objectives, e.g. IDMP, SPOR, MDM, and SPL.
Works collaboratively with GRA staff and R&D IT to support implementation of technology for regulatory submissions and informatics.
- Drives and oversees the maintenance and implementation of global regulatory systems and tools for product information, submissions management and other regulatory information to support GRA.
- Participates in GRA initiatives and represents the business/Takeda needs related to technology, systems and Regulatory Information Management to ensure the teams meet their goals and objectives, e.g. IDMP; SPL, Registration Tracking.
- Accountable through vendors and/or a matrix structure for GRA process optimization including but not limited to:
- Providing input in data migration, update/configuration requirements, integration strategies and change management needs for new and existing systems
- Examining technology between/within GRA and other functions within R&D to identify opportunities to improve the overall efficiency of Regulatory at Takeda.
- Establishes, updates, implements and provides guidance on Health-authority required formats, templates, policies, standards and procedures where technology and information management for GRA are impacted.
- Oversee the migration of Regulatory Information as it relates to M&A and Integration activities
- Alerts Regulatory Operations management where there are deficiencies in technologies and implementation planning and recommends optimization and corrective action plans
- Maintains up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, SPL, xEVMPD, IDMP, SPOR, etc.; analyzes new and revised Health Authority Guidances, advises regulatory management of new requirements and recommends a course of action.
- Responsible for managing and overseeing vendor(s) in relation to Regulatory systems projects and deliverables
- Accountable for demonstrating Takeda Leadership behaviors
- Other responsibilities may include:
- Mentoring GRA employees/consultants
- May managing performance assessments and career development activities
- Planning, assigning and directing work in a matrix environment.
- Participating in interviewing, hiring and training of employees/consultants
- Participating in interviewing, hiring and training employees/consultants.
- Bachelor's Degree is required. Scientific or computer-sciences field preferred
- 8+ years of experience in Pharmaceutical industry, with 6+ years in Regulatory Affairs, research and development, Information Technology or quality assurance/compliance.
- 3+ years of experience in electronic document management technology.
- Knowledge of the requirements for electronic submissions to regulatory authorities. Experience with regulatory /document management systems (e.g. Documentum, FirstDoc, eCTDXpress, Validation tools, Registration tracking, etc. ) is highly preferred
- 5 years of submissions and/or information management experience from a technical solutions strategic level, preferably within a corporate environment supporting multi-user systems International experience is strongly desired.
- Experience in global drug development regulations, regulatory submissions, life cycle management, compliance, business systems technology and process are required.
- Knowledge and experience with industry standards is required. Experience with applying knowledge of information management involving undefined frameworks with medium technical complexity and defined scope. Proven ability to liaise with Regulatory Agencies related to data/systems standards.
- Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Must have experience with industrial interpretation with respect to regulatory
- Experience managing vendors and contracts is strongly preferred.
- Project Management qualification is strongly preferred.
- Provides regulatory advice and making reasoned decisions on regulatory systems issues for which there may not be clear/specific regulatory guidance.
- Demonstrates leadership, problem-solving ability, flexibility and values teamwork.
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Exercises good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Active participation in Agency/Industry groups/forums preferred.
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
- Excellent analytical and communication skills both verbal and written.
- Ability to effectively present information to senior management. Regulatory authorities, staff, public groups and other departments.
- Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
- Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict.
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making.
- Strong interpersonal, managerial and organizational skills.
- Strong technical and problem-solving skills, with an ability to understand and translate business issues and requirements
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods. techniques and evaluation criteria for obtaining results.
- Ensures budgets, schedules and performance requirements are met.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.