Regulatory Affairs Operations Director

About the Role

We are seeking an experienced Regulatory Affairs Operations Director to lead our regulatory information management (RIM) program globally.

The successful candidate will be a strategist, collaborator, and confident leader with a solid understanding of RIM and a passion for driving meaningful changes to support our current and future RIM goals.

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• Translate Global RIM-Related Regulations into Business Requirements: Develop 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: Serve as a subject matter expert on technologies and processes related to registration documents, submission records, and associated product data records.
  
• Daily Business Administration of Regulatory Systems: Responsible for the daily business administration of Regulatory systems, including user management, training, issue escalation, and resolution, and working with IT and third-party providers.
  
• Data Governance Model: Implement a robust data governance model and provide oversight for the management of master data in collaboration with IT and cross-functional teams.
  
• Business Process Development: 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.
  
• RIM Configuration: Understand business processes, regulatory, and reporting requirements and convert these into RIM configuration ideas/proposals.
  
• RIM System Configuration: Configure RIM (Sandbox, Validation, and Production environments) as per agreed proposals.
  
• System Alignment: Work with other Business and System Leads across PTC to ensure alignment of data, system configurations, and user experience.
  
• Regulatory Systems Project Delivery: Execute and deliver Regulatory systems projects, including new implementations, mergers, upgrades, and enhancements.
  
• Cross-Functional Initiatives: Provide leadership for cross-functional initiatives on system and information integration impacting Regulatory information/data.
  
• Regulatory Reporting and Analytics: Provide on-time business support related to all Regulatory Reporting and Analytics requests from RIM.
  
• Documentation and Revision of Regulatory Affairs Systems SOPs: Responsible for driving the documentation and revision of all Regulatory Affairs systems SOPs and work instructions for applicable systems.
  
• Emerging Electronic Standards Development: Monitor and/or participate in emerging electronic standards development or Health Authority requirements; assess impact to the business and develop future plan for adoption.
  
• Training Development: Drive the development and updates for training presentations and other relevant training material for Regulatory systems.
  
• Enterprise Systems Management: Works collaboratively with IT business partners in the management of enterprise systems, the development and adherence to data standards.
  
• Robust Data Foundation: 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.
  
• Tech Trends and Applicability: Partner with vendors and/or IT business partners in keeping abreast of technology trends and applicability to business needs.
  
• Global Environment Collaboration: Collaborates on technology initiatives and applies leadership skills by working in a global environment with business colleagues across functional teams including Clinical, BioStats, DSPV, and CMC.
  
• Culture of Quality and Excellence: Promote a culture of quality, operational excellence, and continuous improvement, supporting company growth and management.
  
• Management and Development: Manage, and develop direct reports within the function, overseeing contractors and vendors that support the function.
  

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• Education and Experience: 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.
  
• Regulatory Knowledge: Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA, and MHRA.
  
• Regulatory Technology Knowledge: Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5).
  
• Drug Development Knowledge: Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.
  
• Audit Fundamentals and Management: Strong knowledge and expertise in audit fundamentals and managing audit programs.
  
• Regulatory Software Management: Assists in managing Regulatory software as directed by management. Provides regular consultation to various RD business partners and RD stakeholders.
  
• Compliance Culture Support: Supports a culture of compliance while encouraging a culture of innovation.
  
• Leadership Skills: Crisp decision-making and recommendations following appropriate consultation, even in times of ambiguity. Ability to think strategically.
  
• Communication and Writing Skills: 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.
  
• Problem-Solving Ability: Requires a high degree of problem-solving ability; understanding objectives and processes across IT and RD functions; and implores solid judgment to determine when management escalation is necessary.
  
• Quality Assurance/Compliance Experience: 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.
  
• Technical Skills: Strong knowledge of MSWord, Excel, PowerPoint, SharePoint, Outlook, and special knowledge or skills needed and/or licenses or certificates required.
  
• Influence and Consultation: 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: Vault RIM implementation and training experience.
  
• Regulatory Intelligence Database Experience: Experience and familiarity with regulatory intelligence databases processes.
  

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• Estimated Salary Range: $194,000 –$244,300 USD
  
• Benefits: 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: 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, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status, or any unlawful criterion under applicable law.