Senior Manager, Regulatory Operations

Senior Manager, Regulatory Operations

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Director, Regulatory Operations at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Senior Manager of Regulatory Operations (Reg Ops) is responsible for supporting key functions within the Regulatory Operations team and across the Vericel organization. This includes the planning, submission management, and submission of regulatory applications, reports, and other documents required for product approvals and maintaining a compliant US License Marketing Authorization requirement, for biologics and devices products. The Senior Manager plays a critical role in ensuring compliance with regulatory requirements and enabling successful product development and distribution activities, for process improvement, vendor management, functional excellence, compliance with regulatory guidelines, regulatory health authority interactions, team management, leadership, and document management systems (RIMS).

The Senior Manager champions process improvement and functional excellence initiatives within the Regulatory Operations team. This includes identifying opportunities for optimizing processes, systems, and tools to improve the speed and cost-effectiveness of regulatory operations while maintaining data integrity and quality. The Senior Manager may also lead or participate in cross-functional teams to implement process improvements and drive operational excellence. Ensuring compliance with relevant regulatory guidelines, including 21 CFR and FDA/ICH guidelines, throughout the regulatory operations processes. Participate in interactions with regulatory health authorities, staying up to date with changes in regulations and industry standards and ensuring that regulatory submissions and documents are in compliance with current requirements.

ESSENTIAL FUNCTIONS

• Lead the business process of overall selection, implementation, and requirements for regulatory information management (RIM) systems: This involves taking ownership of the RIM systems used by Regulatory Operations and driving the selection, implementation, and ongoing management of these systems. This includes developing short and long-term roadmaps for RIM systems to align with the evolving needs of Regulatory Operations.
• Provide business ownership and strategic direction for RIM systems: As a leader in Regulatory Operations, it is important to provide strategic direction for RIM systems and ensure that they align with the overall business objectives. This involves collaborating with cross-functional teams such as Clinical, BioStats, PV, and CMC to understand their needs and aligning RIM systems accordingly.
• Collaborate on technology initiatives and work in a global environment: Regulatory Operations often works in a global environment with colleagues from various functional teams. Collaborating on technology initiatives, such as implementing new systems or upgrades, requires effective leadership skills to drive the project and ensure successful implementation.
• Promote a culture of quality, operational excellence, and continuous improvement: Regulatory Operations plays a critical role in ensuring compliance with regulatory requirements. Promoting a culture of quality, operational excellence, and continuous improvement is essential to maintain compliance and support the growth of the company.
• Partner with vendors and/or IT business partners: Regulatory Operations often relies on technology solutions provided by vendors or IT business partners. Building effective partnerships with these stakeholders is important to stay updated on technology trends, assess their applicability to business needs, and ensure that the technology solutions are effectively integrated into Regulatory Operations processes.
• Define and implement standards and process efficiencies for submission publishing and change management: Submission publishing is a critical aspect of regulatory operations, and defining standards and process efficiencies for this function is essential to ensure timely and accurate submissions. Change management communications are also important to effectively communicate updates and changes to internal stakeholders. Implementing efficient processes and standards for these functions is essential for smooth operations in Regulatory Operations.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

• Bachelor’s Degree required.
• Advanced degree (or progress towards one) is desired but not preferred.

Experience

• 6+ year of Regulatory Operations or related roles required.
• 10+ years of Regulatory Operations or related roles preferred.
• Working knowledge of drug laws, regulations and guidelines is essential.

Qualifications

• A solid understanding of Regulatory Affairs/Operations and expertise in submission and project management.
• Excellent technical understanding and proven, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools, Veeva Vault RIM, SmartSheetes, and off-the-shelf and plug-in software for Authoring Templates, DXC Toolbox that supports the global Regulatory business.
• Strong understanding of Microsoft Office Suite (Word, Excel, Power Point, MS Project)
• Highly collaborative team player that can communicate clearly to both technical and non-technical stakeholders to understand challenges and drive for win-win outcomes.
• Exceptional problem-solving skills and ability to formulate innovative solutions that demonstrate both strategic and tactical thinking.
• Demonstrated ability to organize, prioritize, and execute projects to completion.
• Excellent judgment and interpersonal skills, consensus and relationship building.

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