Job Description Summary:

The Director (Regulatory Information Management and Technology), Regulatory Affairs Operations leads the regulatory information management (RIM) program for PTC globally. This individual is a strategist, collaborator, and confident leader that understands the complexities of RIM and is passionate about driving and delivering meaningful changes to support our current and future RIM goals.The position requires a solid understanding of Regulatory Affairs/Operations and extensive hands-on expertise in Regulatory specific technology (e.g. Veeva Vault RIM), excellent business analysis and project management skills.This individual collaborates with Global Regulatory Affairs and other cross-company functions in driving the development and refinement of our existing and desired global processes to support a robust RIM program to take PTC into the future.The Director (RIM and Tech), Regulatory Affairs Operations supports PTC's compliance with relevant health authority requirements including, but not limited to, Food and Drug Administration (FDA) and European Medicines Agency (EMA) by appropriately applying the principles of Good Clinical Practice (GCP) (e.g. ICH Guideline E6), company Standard Operating Procedures (SOPs), and other directives.Job Description:

Responsibilities:

• Translate global RIM-related regulations into meaningful business requirements and solid action plans to support current and future RIM initiatives over the next 1-2 years
• Subject Matter Expert on technologies and processes related to registration documents, submission records and associated product data records
• Responsible for the daily business administration of Regulatory systems (e.g. Veeva Vault RIM, SharePoint, etc.), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers
• Implement a robust data governance model; provide oversight for management of master data (in collaboration with IT, cross functional teams)
• Drive the development and/or refinement of business process maps by working cross-functionally to identify future state process requirements and documentation to support the desired future state
• Understand the business processes (across R&D and Manufacturing), regulatory and reporting requirements and converting these into RIM configuration ideas/proposals
• Configure RIM (Sandbox, Validation, and Production environments) as per the agreed proposals
• Working with other Business and System Leads across PTC to ensure alignment of data, system configurations and user experience
• Responsible for the execution and delivery of Regulatory systems projects (new implementations, mergers, upgrades, and enhancements)
• Provide leadership for cross-functional initiatives on system and information integration impacting Regulatory information/data
• Responsible for providing on-time business support related to all Regulatory Reporting and Analytics requests from RIM
• Responsible for driving the documentation and revision of all Regulatory Affairs systems SOPs, and work instructions (WIs) for applicable systems
• Monitor and/or participate in emerging electronic standards development or Health Authority requirements; assess impact to the business and develop future plan for adoption
• Drive the development and updates for training presentations and other relevant training material for Regulatory systems
• Works collaboratively with IT business partners in the management of enterprise systems, the development and adherence to data standards
• Maintain a robust data foundation across Global Regulatory Affairs/Operations processes and systems in order to make information accessible and connected to support regulatory business cases
• Partner with vendors and/or IT business partners in keeping abreast of technology trends and applicability to business needs
• Collaborates on technology initiatives and applies leadership skills by working in a global environment with business colleagues across functional teams including (but not limited to) Clinical, BioStats, DSPV, and CMC
• Promote a culture of quality, operational excellence and continuous improvement, supporting company growth
• Management, and development of direct reports withing function
• Oversight and management of contractors and vendors that support the function

Qualifications:

• Bachelor's degree in a scientific or technical discipline or a minimum of 10 years of relevant Regulatory Affairs professional experience in a pharmaceutical, biotechnology, CRO or related environment

• Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA and MHRA.
• Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5).
• Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.
• Supports a culture of compliance while encouraging a culture of innovation.
• Strong knowledge and expertise in audit fundamentals and managing audit programs.
• Assists in managing Regulatory software as directed by management. Provides regular consultation to various the R&D business partners and R&D stakeholders.
• Assists in delivering periodic training to stakeholders on topics related to system compliance, 21 CFR Part 11, and best practices.
• Participates as business owner for the implementation of new systems or major upgrades to existing systems.
• Maintain essential IT infrastructure, including operating systems, security tools, applications, servers, email systems, laptops, desktops, software, and hardware
• Manage user groups and create and maintain archives of Regulatory Affairs systems
• Provide Tier 1 support for end users and escalate issues to IT.
• Reviews and or approves validation deliverables/documentation during the validation process (e.g., validation plans, user requirements, functional specifications, installation qualification, operational qualification, user acceptance testing, traceability matrices and validation summary reports).
• Reviews and approves proposed changes to GxP R&D systems and determines the necessary
• Assists with the development and management of strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections, inspections and investigator site audit inspections for assigned programs.
• Provide input and support to the Quality Operations team, as needed.
• Collaborative team player with a positive attitude who has the ability to think and act quickly and identify creative solutions to complex problems.
• A self-starter, who is able to define, prioritize and manage tasks within a project.
• Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity. Ability to think strategically.
• Strong judgment and decision-making skills; demonstrated ability to take a big-picture approach to decision-making while taking account of the broad interests of Regulatory Affairs.
• Strong communication and technical writing skills. Ability to write briefing documents, quality positions, audit reports and SOPs. Strong attention to detail with the ability to articulate quality related risks and potential impact
• Requires a high degree of problem-solving ability; understanding objectives and processes across IT and R&D functions; and implores solid judgment to determine when management escalation is necessary.
• Broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena (ideally within the clinical and/or non-clinical areas), the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements.
• Strong knowledge of MSWord, Excel, PowerPoint, SharePoint, & Outlook

* Special knowledge or skills needed and/or licenses or certificates required.

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Vault RIM implementation and training experience.
• Experience with Microsoft Word, StartingPoint Templates, ISI/TRS/DXC Toolbox, Adobe Acrobat, and electronic publishing software.
• Experience and familiarity with regulatory intelligence data bases processes

* Travel requirements: 0-10%

*Expected Base Salary Range:

$194,000 -$ 244,300 USD .The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement:

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PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, p regnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.