Opella · 6 days ago
Global Regulatory Brand Lead Allegra
Morristown, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$180K/yr - $220K/yr
10+ years expOpella is the self-care challenger with a significant presence in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market. They are seeking a highly experienced Global Regulatory Brand Lead to drive regulatory success for the Allegra brand portfolio, focusing on brand growth and regulatory compliance.
Health CarePersonal HealthRetail
Responsibilities
Develop and Champion Strategy: Define and execute the comprehensive, long-term regulatory strategy for all Allegra brand products globally, ensuring alignment with commercial goals
Lead Complex Submissions: Direct and manage major regulatory procedures worldwide, including EU procedures (DCP/MRP), and provide expert guidance on clinical trial applications and evidence generation
Drive Innovation Pipeline: Serve as the regulatory lead in the global innovation process, providing crucial scientific and regulatory input for new product development, complex CMC applications (e.g., formula upgrades), and market entry
Opportunity Identification: Proactively monitor regulatory trends and intelligence to identify new product opportunities and potential risks, presenting actionable recommendations to the Business and Regional Heads
Brand Portfolio Accountability: Act as the regulatory portfolio owner, ensuring timely and compliant maintenance of all existing registrations (e.g., PBRERs, annual reports, variations)
Risk Management: Proactively identify and communicate potential regulatory risks (e.g., submission delays, PRAC announcements, Rx status changes) to senior management, offering clear mitigation options
Quality & Process Excellence: Ensure all activities adhere to internal Quality Management System standards, while actively seeking opportunities to streamline and improve global regulatory processes
System Compliance: Oversee and monitor adherence to global regulatory systems (e.g., Veeva) for the brand portfolio
Cross-Functional Leadership: Serve as the definitive Regulatory voice in core internal committees, acting as a strategic partner to R&D, Medical, Commercial, and Operations teams
Problem Solving: Lead the analysis of complex regulatory challenges, providing clear, solution-oriented recommendations and securing necessary endorsements from Global Regulatory Leadership
Global Network Coordination: Manage effective interactions with Country Regulatory teams, providing consistent advice, leveraging synergies across submissions, and ensuring timely communication to manage workload and local compliance
Regulatory Intelligence: Monitor external regulatory intelligence, sharing critical insights and alerts with relevant internal stakeholders
Qualification
Required
Bachelor's Degree in Science (e.g., Pharmacy/Pharm D, Biology, Chemistry) or a higher degree (Ph.D.)
Minimum 10+ years of progressive experience in Regulatory Affairs within the Consumer Healthcare or Pharmaceutical industry
Demonstrated success in developing and executing complex regulatory strategies for OTC products across multiple global regions and different product categories (including Drugs, Food, Medical Devices)
Proven experience in a global lead regulatory role with a comprehensive understanding of regional regulatory requirements and dynamics
In-depth knowledge of major markets, particularly USA and EU (including EU centralized and decentralized procedures), for Drugs and Medical Devices legislation
Practical experience and knowledge of Clinical Trial Applications (CTAs) and CMC (Chemistry, Manufacturing, and Controls) sciences
Exceptional strategic and critical thinking skills with the ability to analyze complex situations and condense information into clear, executive-level summaries and recommendations
Strong sense of urgency and ability to react decisively to regulatory alerts, product challenges, and sustainability trends
Proven leadership ability to mentor and guide junior associates
Excellent communication and interpersonal skills, with a collaborative mindset for working in a global, matrixed environment
Fluency in English is essential
Preferred
A specialized degree in Regulatory Affairs is highly desirable
Benefits
Employees may be eligible to participate in Company employee benefit programs.
Additional benefits information can be found through the LINK.
Company
Opella
Opella is a consumer healthcare business segment of Sanofi.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-20Acquired
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