Head of Regulatory Operations

Red Nucleus is hiring a Head of RegOps to join our global team! This role can be based out of our US offices or full-time remote in the US.

Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 900 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".

How You Will Contribute

In this position, you will be working with our global RegOps team. For more information about our team, please visit RegOps I Red Nucleus.

As a Head of Regulatory Operations, you will be leading a team of expert regulatory operations publishers supporting our clients critical regulatory filing needs by producing consistently high quality, on-time and on-budget results.  The Head of Regulatory Operations develops the vision and market positioning of the Red Nucleus (RN) Regulatory Operations team within the overall RN go-to-market strategy.  The Head of Regulatory Operations develops and manages the business development efforts supporting the RegOps group, including actively engaging in the business development activity.  The Head of Regulatory Operations is responsible for establishing and maintaining standards for the group in partnership with their leadership team.  And the Head of Regulatory Operations is responsible for the hiring, growth and utilization of the RegOps team members in partnership with their leadership team.

Primary Responsibilities:

Strategic Leadership: Strategically drives Company objectives.

• Proactively lead RegOps organization and contribute to growth and brand recognition.
• Accountability for RegOps sales and revenue targets between $7M-$10M annually
• Contribute to the strategic growth of RN – ability to see and leverage capabilities across divisions/regions.
• Overall P&L and budget management for RegOps, including sales and revenue projections and reporting
• Staff utilization management and RegOps gross margin accountability
• Vendor management and collaboration for internal technology solutions

Account Management: Provides timely delivery on all client engagements and internal initiatives.

• Independently source sales opportunities for RegOps
• Independently manage sales pitches and RFP responses for new or existing clients
• Partner with Red Nucleus sales to manage sales pitches and RFP responses for new or existing clients
• Maintain RegOps specific content for marketing newsletters and Red Nucleus website
• Create/review all RegOps related project contracts and pricing estimates and manage client negotiations and service-related questions
• Management of RegOps sales pipeline in Salesforce
• Client leader and account management responsibilities.
• Ensure Margins on projects are maintained per RN objectives.
• Seen by the client as the “go-to” person for RN in request for new business, for discussion of challenges, etc.
• Drives new business opportunities. Ability to identify business opportunities in key accounts, leading to $7M-$10M in sales.
• Ability to manage growth in multiple key accounts
• Ability to make introductions to new accounts for RN

Delivery Excellence: Ability to strategically oversee global project delivery.

• Developing and maintaining division strategy.
• Supervising division or subdivision of staff.
• Accountable for team performance.
• Lead others in problem solving and addressing engagement challenges.
• Right first time across the board, internal and client deliverables for self and team.
• Thinking “outside the box” as it pertains to deliverables – internal and client related.
• Accountable for quality of work for RegOps team, in multiple accounts.
• Ability for “hands-on” client delivery for complicated or at risk projects
• Seen as an industry leader for a region or division.
• Establishing novel approaches to delivery and deliverables.
• Contributing to impactful strategies and significant growth for RN.  Ability to leverage strategies across all of RN.

Productivity, Dependability, and Flexibility: Reliable, efficient, and adaptable to accommodate company objectives.

• Proactivity supporting the business and staff in meeting objectives.
• Accountability for overseeing other consultants’ deliverables (right the first time).
• Can manage a team with high-yield deliverables.
• Flexible in leadership and ownership to take the division to the next level.
• Solid ability to multi-task without delay or being overwhelmed.
• Dependable and flexible.
• Proactivity supporting the partners in meeting the Company’s overall objectives (financial, operational and execution).
• Contributing to a foundational presence in the industry as a trusted partner and leader.
• Ensuring RN’s RegOps processes are compliant and efficient

Cross Business Unit and Other Support

• Partner with Advisory team on RIM related initiatives (if/as needed)
• SME support for RN Products team to input into development of proprietary Content Management Solution
• Oversee and support client, Health Authority, and internal RN audits as it pertains to the RegOps team and projects
• Support other RN business units/divisions (Medical Communications, Learning & Development, Market Access, Clinical, Advisory) with cross-BU business development initiatives and with introductions to key client contacts

You will be working alongside seasoned consultants, subject matter experts and industry specialists to ensure that all client deliverables meet customer expectations. You will be expected to actively contribute to the global submission and RIM processes across the RegOps division.  The role will require you to represent Red Nucleus in addressing the client’s business requirements and needs including:

• Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.
• Project Management across all R&D contributors to global submissions
• Effectively communicate global Regulatory requirements and industry best practices to clients.
• Provide guidance to RegOps team to plan all submission management related activities.
• Lead and support clients in global submissions (including, assessment and implementation of document management and labeling technology solutions, establishment of processes, full out-source support of submissions).
• Lead and support RegOps team on Regulatory and publishing related issues and topics
• Analyze submissions and track and record life-cycle information in accordance with standards.
• Keep updated on regulatory authorities’ requirements on technical/format aspects of submissions worldwide and ensure their incorporation into Red Nucleus standards.
• Review, identification and classification of regulatory documentation in support of data migration projects

About You

• Bachelor’s degree (minimum requirement)
• A qualified candidate must be detail oriented with a high sense of self-initiative.
• 15-20 years of experience in the pharmaceutical industry with a focus in Global Regulatory Operations.
• 15-20 years of experience publishing, submitting and managing global documents and submissions in a document repository.
• Experience driving strategy for Global Regulatory teams
• Experience managing and forecasting departmental budgets, including but not limited to, revenue, P&L, sales, gross margins.
• Experience in project managing major (NDA, MAA, etc.) submissions.
• Understanding of global drug development documents.
• At least 15 years of experience with global publishing
• At least 15 years of experience with regulatory global registration management information and systems.
• Experience with the implementation of a regulatory technology such as, Veeva, Documentum, First Docs, etc.
• Experience in the migration of documents and submissions from one regulatory system technology to another.
• Proficient in Microsoft Suite software including Excel, Word, Powerpoint, Visio
• Proficient with industry standard RIM/submission management software.
• Ability to travel up to 50%

What You Will Enjoy at Red Nucleus

• Competitive pay, incentives, retirement, and income security programs
• Comprehensive benefits and wellness programs focused on healthy lifestyles
• Generous paid time off, employee assistance programs and flexible work arrangements
• Performance-driven environment including professional development and transfer opportunities
• People-first culture fostering self-expression, diversity, and a growth mindset
• Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
• Support of the community organizations you are passionate about
• Ongoing programs and events designed to bring our global team together

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit.  We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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