Global Regulatory Brand Lead Allegra

Opella•Morristown, NJ

33d

About The Position

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. About the job: We are seeking a highly experienced and strategic Global Regulatory Brand Lead to drive the worldwide regulatory success of the Allegra Global Brand portfolio. This is a senior, high-impact role responsible for setting and executing the regulatory vision, leading complex global submissions, and acting as the primary strategic regulatory partner to the stakeholders. The focus is two-fold: accelerating brand growth through global innovation and ensuring strong regulatory compliance for the existing portfolio.

Requirements

Bachelor's Degree in Science (e.g., Pharmacy/Pharm D, Biology, Chemistry) or a higher degree (Ph.D.). A specialized degree in Regulatory Affairs is highly desirable.
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.

Responsibilities

Global Regulatory Strategy & Innovation 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.