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Senior Manager, Regulatory Operations
Posted about 10 hours agoViewed
💎 Seniority level: Senior, 4+ years
💸 Salary: 95000.0 - 115000.0 USD per year
🔍 Industry: Pharmaceutical advertising
⏳ Experience: 4+ years
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.
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
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