Job Summary: 

• Lead and manage the regulatory program for a range of genetically engineered traits and products in soybeans as well as the food products made from those soybeans
• Map out the regulatory framework and requirements for genetically engineered traits in development through to launch
• Successfully interact with USDA/APHIS and FDA
• Prepare and obtain permits and notifications for field release and movement of organisms and crop material
• Contribute to the preparation of data packages to be submitted to USDA/APHIS and the FDA
• Be the company authority on and communicator of biotechnology regulatory policies
• Oversee regulatory aspects of and maintain records related to the execution of field trials
• Manage shipment and receipt of organisms and crop materials
• Manage internal regulatory inventory and documentation files
• Conduct regulatory training for employees
• Effectively manage change to ensure compliance with regulatory affairs and the changing global regulatory landscape
• Guide subordinates to achieve goals
• Exercise the usual authority of a manager including selection and development of staff, talent acquisition, and performance management

Skills on Resume: 

• Regulation Management (Hard Skills)
• Compliance Assurance (Hard Skills)
• Agency Interaction (Soft Skills)
• Data Preparation (Hard Skills)
• Trial Oversight (Hard Skills)
• Team Leadership (Soft Skills)
• Training Delivery (Soft Skills)
• Change Management (Soft Skills)

Job Summary: 

• Provide general direction, tactical objectives, and functional plans for execution of the Regulatory Affairs Department
• Develop strategy and key initiatives for DJO Surgical’s business about Regulatory Affairs and product registration pathways globally
• Develop, communicate, and track goals necessary to the success of the Regulatory Affairs Department, as it relates to the success of the Company
• Partner with Sales, Customer Service, R&D, Operations, and Logistics to ensure appropriate compliance and activities for a regulated Medical Device organization
• Develop product registration pathways in the US, Europe, Japan, Australia, and other global regions to meet the needs of the DJO Surgical business and its overall strategic plans
• Support product and business acquisitions about Regulatory requirements and product acquisition and transfer
• Be a point of contact for Regulatory agencies globally, as they relate to DJO Surgical products
• Know global product pathways including EU CE (MDD and MDR), Japanese MHLW, Australian TGA, and others
• Partner closely with Clinical Affairs to ensure proper clinical strategies and execution to support the Regulatory product pathways for both approvals and maintenance
• Responsible for monitoring product safety as well as adverse event assessment and reporting
• Responsible for DJO Surgical Regulatory Affairs Special Processes not otherwise listed.
• Ensures that all policies and strategies at DJO Surgical are in full compliance with all applicable regulatory requirements while still maintaining operational efficiency for the company
• Regularly consult with business leaders to develop corrective action plans and strategies to improve the business processes and results

Skills on Resume: 

• Regulatory Strategy (Hard Skills)  
• Global Compliance (Hard Skills)  
• Cross-Functional Collaboration (Soft Skills)  
• Product Registration (Hard Skills)  
• Agency Communication (Soft Skills)  
• Clinical Strategy Alignment (Soft Skills)  
• Safety Monitoring (Hard Skills)  
• Process Improvement (Soft Skills)  

Job Summary: 

• Manage departmental annual budget and be responsible for overseeing team spending.
• Provides objectives and communication of strategies, priorities, and direction to staff.
• Sets expectations for direct reports, mentors key personnel, and provides coaching to regulatory staff.
• Maintain excellent communication and relationships with other people to foster real team effort within the company.
• Manage submissions of EPA applications to update and maintain existing product registrations.
• Work across multiple, internal organizations with varying outputs.
• Partner with and communicate with cross-functional teams providing regulatory input and compliance needs for products and product development.
• Ensure regulatory compliance needs for products are communicated to cross-functional teams.
• Support Quality Assurance, Purchasing, and Manufacturing regarding inspections recalls, and product reviews by regulatory agencies.
• Apply knowledge and experience in the regulatory field within work teams, interacting with peers and direct reports.
• Prepares and presents results, both written and oral to various levels of management.
• Advise and communicate to the company on regulatory issues, aspects and climate that would affect proposed activities.
• Manage consultants that provide regulatory services to expand product markets and defend brand equity.
• Leverage and maintain relationships with key AAFCO, EPA, FDA, and DOT regulatory officials and trade organizations in the US, Canada, Mexico, EU, and other foreign governments.

Skills on Resume: 

• Budget Management (Hard Skills)  
• Team Leadership (Soft Skills)  
• Regulatory Compliance (Hard Skills)  
• Submission Management (Hard Skills)  
• Cross-Functional Collaboration (Soft Skills)  
• Agency Communication (Soft Skills)  
• Staff Mentoring (Soft Skills)  
• Consultant Oversight (Soft Skills)  

Job Summary: 

• Proactively develop new innovative approaches
• Accountable for alignment of regulatory strategy to business strategy across all functional areas
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with members of Regulatory and other cross-functional teams
• Accountable for regulatory strategy and vision within the business unit
• Identify risk areas within the global business unit and develop alternative courses of action including anticipation of regulators' responses through scenario planning and development of contingency plans working with cross-functional partners
• Negotiate and interact with the regulatory authorities including the oversight, planning and leadership of meetings
• Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global registrations
• Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
• Develop and manage the budget for the business unit RA group
• Recruit, develop, and lead a team of regulatory professionals in the development of strategic plans and regulatory submissions
• Oversee team management and development
• Engaged in policy development within the organization and with external groups
• Guide proactive relationships with regulatory authorities to facilitate interactions for critical issues
• Influence the direction of the regulatory function
• Ensure development of competencies and capabilities for current and future goals

Skills on Resume: 

• Innovation Development (Soft Skills)  
• Regulatory Alignment (Hard Skills)  
• Risk Management (Hard Skills)  
• Agency Negotiation (Soft Skills)  
• Submission Oversight (Hard Skills)  
• Team Leadership (Soft Skills)  
• Policy Development (Hard Skills)  
• Competency Building (Soft Skills)  

Job Summary: 

• Translate regulatory strategies into executable plans for the portfolio of products.
• Work with a team to find creative solutions to tackle challenges.
• Support regional and country product registrations and supervise and assess impacts of product-specific regulations.
• Lead New Product Development and Life Cycle regulatory activities, working closely with cross-functional partners, as well as global Regulatory Affairs affiliates.
• Direct and coordinate the preparation and submission of regulatory information required to acquire global market access, identify risks and issues, effectively communicate timelines for project completion, and address sophisticated issues that may impact registration status.
• Work with Health Authorities to acquire feedback before submission, expedite approval of pending applications and resolve other regulatory matters.
• Provide regulatory CMC strategic leadership to support development programs
• Partner with cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
• Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase-appropriate considerations and comparability needs
• Serve as the Regulatory Affairs representative on CMC teams
• Lead communications with regulatory agencies related to CMC strategies and issues
• Manage and implement planning, authoring and submission of high-quality CMC‑related briefing documents and CMC portions of regulatory applications
• Assess and communicate CMC regulatory requirements to ensure all development activities comply with applicable regulations and guidelines
• Interpret regulations and guidance to provide advice to company leadership and CMC teams
• Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team

Skills on Resume: 

• Strategy Execution (Hard Skills)  
• Problem Solving (Soft Skills)  
• Registration Support (Hard Skills)  
• Team Collaboration (Soft Skills)  
• Agency Interaction (Soft Skills)  
• CMC Leadership (Hard Skills)  
• Regulatory Compliance (Hard Skills)  
• Team Development (Soft Skills)