Revelation Pharma · 9 hours ago
VP of Regulatory Affairs
Kennesaw, GA
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expRevelation Pharma is a company focused on regulatory affairs within the pharmaceutical industry, seeking a Vice President of Regulatory Affairs to lead their regulatory strategy. The role involves ensuring compliance across facilities, developing quality systems, and fostering a culture of operational excellence.
Health CareMedicalPharmaceutical
Responsibilities
Partner with the COO to develop and lead the enterprise-wide regulatory strategy
Define and communicate clear regulatory objectives and expectations across pharmacies and RPC departments
Act as a trusted advisor to executive leadership on regulatory risk, compliance priorities, and industry trends
Work alongside RPC departments to support corporate goal of instilling a Culture of Excellence, Financial Performance, and Focus on Quality with all RPC employees
Develop methods to embed regulatory compliance into compounding processes for Revelation facilities
Responsible for development, implementation, maintenance and overall success of Revelation’s regulatory compliance strategy and programs
Coordinate with Quality Assurance to ensure adequacy of departmental and company standard operating procedures (SOPs) that ensure adherence to cGMP, FDA, DEA, USP <795>, <797>, <800>, state, and federal regulatory requirements
Implement, monitor, and promote best practices to ensure compliance with relevant FDA, federal and state regulations/directives/requirements
Liaise with Government Affairs (GA) to understand current and upcoming regulatory matters that affect Revelation functions. Work with GA to affect positive change for Revelation and ensure continued compliance as new regulatory needs arise
Oversee regulatory strategy and submissions in compliance with all applicable regulatory requirements and in alignment with corporate goals
Serve as the lead corporate representative during regulatory inspections and oversee timely and effective responses
Develop and maintain relationships with outside regulatory counsel to effectively and efficiently manage their resources and expertise
Monitor changes in the regulatory environment and proactively update policies and processes to ensure compliance
Oversee processes for internal and external compliance audits
Maintain inspection readiness and respond to findings from audits
Develop and implement metrics-driven approaches to assess and improve regulatory compliance across all compounding operations
Other responsibilities as requested by management
Collaborate with R&D, Marketing, Operations, and other internal stakeholders to ensure compliance and support new product development and commercialization
Provide regulatory-centric thinking in all phases of the product lifecycle
Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of compliance
Lead, mentor, and develop a high-performing Regulatory Affairs team with a focus on excellence, accountability, and growth
Qualification
Required
Bachelor's degree required; advanced degree preferred (e.g., PharmD, MS in Regulatory Affairs or related discipline)
Minimum of 5 years in senior QA/RA leadership within a pharmaceutical or healthcare-related environment
Demonstrated success managing multi-site operations and regulatory inspections (FDA, State Boards of Pharmacy, etc.)
Expert knowledge of compounding regulations and industry standards (503A/503B, cGMP, DEA, USP chapters <795>, <797>, <800>)
Strong leadership, communication, and change management skills
Ability to deliver effective training and public presentations in both in-person and virtual formats
Track record of fostering high-performing, accountable teams
Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines
Commitment to reflect Revelation values: patient centric, relentless, passionate
Company
Revelation Pharma
Revelation Pharma is a national network of 503A and 503B compounding pharmacies providing innovative and quality pharmaceutical products.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Shawn Hodges, PharmD
Chief Executive Officer
Will Skinner, CPA
Chief Financial Officer
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