Mindlance
Location: FC Hybrid
BR: ***/HR
True Job title: PRC Submission Management Lead
*** Sciences is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Key Responsibilities • Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes. • Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault. • Attend PRC meetings to represent submission status, clarify content, and capture feedback. • Triaging and managing review comments from MLR teams, including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure. • Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness. • Provide training and guidance to CPC team members on regulatory guidelines and best practices. • Develop a playbook outlining optimal ways of working across PRC and CPC teams. • Collaborate with ***'s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications • Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations. • Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking. • Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams. • Experience working with agencies and internal content teams to resolve feedback and ensure compliance. • Operational mindset with the ability to streamline processes, identify gaps, and implement best practices. • Prior experience in training and documentation development is a plus. • Familiarity with AI applications in regulatory or marketing contexts is a bonus.
Required Years of Experience: 6-8 years
Top 3 Required Skill Sets: a. Experience in Medical, Legal, and Regulatory (MLR) review process b. Proficiency in Veeva Vault PromoMats c. Project Management and workflow optimization
Top 3 Nice to Have Skill Sets: a. Documentation and process mindset b. Change Management c. Familiarity with AI
Unique Selling Point of this role: a. The position is ideal for someone who wants to influence enterprise-level change, contribute to next-generation regulatory solutions, and work in a high-impact, cross-functional environment that values both subject matter expertise and operational agility.
Required Degree or Certification • Veeva Vault Certification or Training - demonstrating proficiency in the platform • Project Management Certification (e.g., PMP) - helpful for managing review cycles and cross-functional coordination
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
True Job title: PRC Submission Management Lead
*** Sciences is seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with a strong operational focus. The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Key Responsibilities • Serve as a Subject Matter Expert (SME) in US CPC team, ensuring compliance with regulatory standards and internal processes. • Manage end-to-end MLR review cycles, including submission preparation, routing, and tracking through Veeva Vault. • Attend PRC meetings to represent submission status, clarify content, and capture feedback. • Triaging and managing review comments from MLR teams, including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure. • Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness. • Provide training and guidance to CPC team members on regulatory guidelines and best practices. • Develop a playbook outlining optimal ways of working across PRC and CPC teams. • Collaborate with ***'s AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.
Qualifications • Proven experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations. • Strong working knowledge of Veeva Vault, including digital asset submission, routing, and tracking. • Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams. • Experience working with agencies and internal content teams to resolve feedback and ensure compliance. • Operational mindset with the ability to streamline processes, identify gaps, and implement best practices. • Prior experience in training and documentation development is a plus. • Familiarity with AI applications in regulatory or marketing contexts is a bonus.
Required Years of Experience: 6-8 years
Top 3 Required Skill Sets: a. Experience in Medical, Legal, and Regulatory (MLR) review process b. Proficiency in Veeva Vault PromoMats c. Project Management and workflow optimization
Top 3 Nice to Have Skill Sets: a. Documentation and process mindset b. Change Management c. Familiarity with AI
Unique Selling Point of this role: a. The position is ideal for someone who wants to influence enterprise-level change, contribute to next-generation regulatory solutions, and work in a high-impact, cross-functional environment that values both subject matter expertise and operational agility.
Required Degree or Certification • Veeva Vault Certification or Training - demonstrating proficiency in the platform • Project Management Certification (e.g., PMP) - helpful for managing review cycles and cross-functional coordination
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."