Senior Manager, Regulatory Operations

In the journey of life, your career should make a difference.

At Inizio Evoke, we come together—to do the best work, in the best possible place. We're all in. Because it's everyone's role to make health more human™.

About the role:

As a Senior Manager, Regulatory Operations at Evoke, you will work as senior member of the Regulatory department. You will be adaptive to innovative thinking, a willing leader, and will thrive in a deadline-driven and quality-focused environment. Your job will be to ensure and support your team in the delivery of multiple and simultaneous large-scale projects within the businesses you lead. You will be managing the workload of several brands and working to ensure the Regulatory team collaborates and moves work through the various stage of the MLR lifecycle while following client-specific submission guidelines to ensure consistency and compliance across all projects. You will call on knowledge of documented processes and your extensive background to optimize the delivery of compliant materials for high volumes of work, mentor junior team members, and work in partnership with Project and Account Management teams to follow agency process and deliver impeccable work.

This is a fully remote role, reporting to the VP, Associate Operations Director.

Responsibilities:

• Oversight for entire books of business
• Day to day lead for brands with larger scopes
• Manager of Brand Leads (BLs) and Regulatory Operation Coordinators (ROCs)
• Escalation point for BLs with smaller scopes and ROCs
• Support BL and ROC responsibilities as needed
• Review SOWs and Change Orders for the brands they oversee
• Assists in prepping MLR submissions, ensuring compliance of each brand's submission requirements for multiple client teams
• Lead preparation of OPDP binders
• Create submissions folder structures and work with Project Manager on setting up
• Meet with new hires to go over purpose of regulatory department/background on pharma and regulations and onboards with 'Working with RegOps' training deck
• Review resource hours and full department workload to provide delegation recommendations for the RegOps department
• Provide guidance and recommendations per brand standards to BLs and ROCs on creating quality submissions to MLR
• Review sporadic submission routes with attention to brand standards and Evoke process consistency
• Attend internal team statuses, project kickoffs, and host dashboard meetings for their teams
• Verify timing and project requirements proposed in the meetings noted above for all brands they oversee
• Assign submission tasks to ROCs and BLs to ensure timely delivery of submission package
• Communicate with MOPs/MLR Coordinators to confirm expectations and timing requirements are met, exchange information, resolve outstanding procedural questions, and request recommendations
• Document updates to each brand's MLR submission processes/requirements and develops guidelines
• Train and educate ROCs and BLs on each brand's submission policies, processes, and standards
• Collaborate with senior Regulatory team to streamline internal standard operating procedures (SOPs) to facilitate efficient and compliant submissions
• Provide and relay recommendations for improved submissions (i.e., formats and layouts) to ROC and BLs, along with the internal teams
• Identify potential delays or operational obstacles and develop contingency plans

Requirements:

• 4+ years of relevant regulatory experience or operational experience in a pharmaceutical advertising agency.
• Working knowledge of digital marketing environment.
• Proficient in Microsoft Office and Adobe Acrobat.

Inizio Evoke provides an exciting and flexible work environment, great compensation packages and outstanding company paid benefits including medical, dental, 401(k), tuition reimbursement and flexible time off.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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