Regulatory Strategy Manager

About the Organization

We are a compliance-driven entity dedicated to navigating intricate regulatory landscapes to facilitate responsible innovation, sustainable growth, and market access. Our globally distributed teams collaborate across various departments including Regulatory Affairs, Legal, Compliance, Quality, Risk, Product Development, Operations, Government Relations, Clinical/Technical units, and Executive Leadership to craft forward-looking strategies that anticipate regulatory shifts and support long-term business goals.

Key Responsibilities

• Formulate and execute regulatory strategies aligned with company goals, product lines, market entry tactics, innovation projects, and long-term priorities.
• Lead planning for regulatory efforts spanning product development, registration, commercialization, lifecycle management, market expansion, and post-market activities.
• Work closely with teams in Regulatory Affairs, Legal, Compliance, Quality Assurance, Risk, Product, Operations, Clinical/Technical fields, Government Relations, Commercial units, and Executive Leadership.
• Perform regulatory intelligence gathering to track legislation, guidelines, standards, enforcement patterns, policy developments, and emerging regulatory benchmarks.
• Evaluate the impact of regulatory changes on business and recommend strategic responses, deployment plans, and risk mitigation.
• Create regulatory roadmaps for product approvals, licenses, certifications, renewals, variations, market expansion, and related licensing requirements.
• Lead assessments of regulatory gaps, compliance readiness, risk analyses for products, services, technologies, and corporate operations.
• Define and track performance KPIs like submission timelines, approval metrics, regulatory commitments, compliance results, renewal efficiencies, risk exposure, and market access milestones.
• Oversee preparation, review, submission, and upkeep of regulatory dossiers, applications, technical files, authority communications, and correspondences.
• Facilitate interactions with UAE regulatory bodies and other relevant government authorities, ensuring timely and accurate exchanges.
• Develop engagement approaches for new products, technologies, business models, market entries, manufacturing or operational changes, and emerging regulatory categories.
• Assess regulatory consequences of product modifications, technology deployment, manufacturer or supplier changes, labeling updates, software releases, and other lifecycle elements.
• Implement regulatory governance structures governing ownership, submission controls, commitment tracking, documentation, escalation, approval processes, change controls, and decision-making.
• Coordinate cross-functional responses to regulatory inquiries, audits, inspections, findings, and remediation needs.
• Manage regulatory commitments ensuring involved teams are aware of duties, deadlines, documentation, dependencies, and escalation mechanisms.
• Support business development and market entry by analyzing regulatory viability, licensing, approval pathways, restrictions, competitors, and compliance barriers.
• Devise regulatory risk scenarios and contingency plans addressing policy shifts, delays, uncertainty, enforcement, compliance gaps, and access disruptions.
• Ensure compliance of strategies with UAE laws and applicable international standards relevant to the industry and products.
• Promote digital innovation through AI-supported regulatory intelligence, automated change tracking, intelligent document analysis, submission management, compliance analytics, and predictive risk management.
• Utilize systems such as Veeva Vault, MasterControl, TrackWise, SAP, Oracle, Microsoft 365, SharePoint, Power BI, Tableau, alongside regulatory databases and compliance tools.
• Manage budgets and relationships with external consultants, advisors, technology providers, intelligence services, and regulatory projects.
• Produce executive-level reports, intelligence briefings, risk dashboards, submission strategies, impact analyses, compliance evaluations, and strategic recommendations.
• Lead and mentor regulatory affairs specialists, compliance experts, and cross-functional teams fostering a culture of integrity, rigor, accountability, transparency, and continuous enhancement.

Qualifications and Experience

• Bachelor’s degree in Regulatory Affairs, Law, Pharmacy, Life Sciences, Chemistry, Engineering, Healthcare, Public Policy, Business, or related disciplines.
• Master’s degree in relevant fields such as Regulatory Affairs, Public Policy, Law, Pharmaceutical Sciences, or Business Administration is highly desirable.
• Certifications in regulatory affairs, compliance, quality, risk management, or industry-specific regulations are favored.
• Minimum of 5 years’ experience in regulatory affairs, strategy, compliance, government affairs, quality, legal, market access, or equivalent roles.
• At least 2 years overseeing regulatory strategies, market access initiatives, submissions, intelligence programs, or compliance projects preferred.
• Deep knowledge of regulatory strategy, intelligence, compliance frameworks, market access, licensing, submissions, risk governance, government engagements, change management, and industry-specific demands.
• Experience with Veeva Vault, MasterControl, TrackWise, RIM systems, SAP, Oracle, Microsoft 365 suite, SharePoint, Power BI, Tableau, regulatory databases, and compliance tools.
• Familiarity with AI-driven regulatory intelligence tools, automated change monitoring, advanced document review, predictive compliance analytics, and automated submission tracking is a plus.
• Excellent skills in strategic thinking, regulatory interpretation, communication, stakeholder engagement, project management, negotiation, organization, and problem-solving.
• Capability to translate complex regulations into practical strategies, operational guidance, business recommendations, and actionable plans.
• Adept at balancing multiple regulatory projects alongside business priorities and stakeholder expectations within a remote, distributed team setting.
• Willingness and ability to engage in occasional travel for regulatory meetings, audits, inspections, workshops, and market entry events.

Benefits and Offerings

• Fully remote work with flexible collaboration across global multidisciplinary teams.
• Competitive salary with incentives tied to performance outcomes.
• Comprehensive health and wellness programs.
• Opportunities for professional growth and leadership development in regulatory strategy.
• Exposure to cutting-edge AI-powered regulatory tools including automated intelligence, predictive risk analysis, and document management systems.
• A collaborative environment nurturing regulatory excellence, innovation, transparency, and continuous progress.
• Chance to influence regulatory and market access approaches that promote innovation, safeguard interests, ensure compliance, and support sustainable growth.