**Regulatory Affairs – Senior Role Summary** **1. Product Registrations & Submissions** + Provide high‑level regulatory leadership for global development programs and commercial products across **Emerging Markets** (defined as all regions _except_ Switzerland, the United States, Europe, Canada, and Australia). + Define, drive, and optimize global regulatory strategies, ensuring full alignment with cross‑functional stakeholders. + Determine data requirements, evaluate scientific evidence against regulatory standards, and ensure robust dossier quality. + Lead the preparation, review, and approval of complex registration packages and responses to agency inquiries. + Maintain complete oversight of filings, approvals, and regulatory documentation throughout the product life cycle. + Develop strategy and briefing materials for Health Authority interactions, ensuring consistent and well‑positioned company messaging. **2. Cross‑Functional Leadership** + Represent Regulatory Affairs in senior internal forums, articulating clear regulatory positions and influencing decision‑making across Development, Manufacturing, Quality, and Commercial functions. + Monitor program execution against strategic plans and timelines, identifying risks and enabling proactive mitigation. + Provide authoritative regulatory insight to support program progression and operational decision‑making. **3. Life‑Cycle Compliance** + Evaluate and approve manufacturing and technical changes with regulatory impact, ensuring timely updates to global submissions. + Ensure investigational submissions remain current throughout all phases of development. + Continuously monitor global regulatory legislation and assess implications for regional business operations and compliance. + Oversee ongoing regulatory compliance of marketed products across their life cycle. **4. Regulatory Strategy & Business Partnership** + Advise senior stakeholders—including Commercial, Quality, Manufacturing, Development, and Business Development—on regulatory requirements and strategic risks. + Define global and regional regulatory pathways for new product registrations and key lifecycle submissions. + Provide expert regulatory assessment and strategic guidance during in‑licensing evaluations and due diligence. **5. Continuous Improvement & Operational Excellence** + Identify opportunities to streamline regulatory processes, enhance operational efficiency, and strengthen cross‑functional execution. + Drive implementation of improved practices that elevate regulatory quality and accelerate timelines. **6. Health Authority Engagement** + Participate in Health Authority meetings, representing company regulatory strategy with clarity, confidence, and scientific rigor. **7. Licensing Responsibilities** + Serve as the primary RA representative for in‑licensing opportunities, independently evaluating regulatory risks, feasibility, and integration pathways. **Core Responsibilities** + Provide strategic regulatory direction for assigned projects, including complex or novel issues. + Lead cross‑functional inputs to create strong regional regulatory plans. + Prepare and oversee high‑quality submissions, ensuring scientific consistency and alignment with company positions. + Track and report program status, escalating issues and recommending solutions where needed. + Deliver clear, persuasive written and verbal communication to internal teams and leadership. + Maintain expert knowledge of evolving regulatory guidelines and translate regulatory intelligence into actionable strategy. + Ensure accuracy, compliance, and scientific integrity of all regulatory deliverables. **Position Scope & Impact** + Operates autonomously with minimal supervision, managing significant regulatory responsibilities across multiple functions and geographies. + Partners closely with EPD RA, Affiliate RA teams, and regional stakeholders in Commercial, QA, Operations, and Development. + Accountable for timely and high‑quality completion of all assigned regulatory activities. + No direct budget responsibility; however, expected to identify cost‑saving opportunities and ensure efficient resource use. + Anticipates regulatory risks, proactively resolves issues, and incorporates learnings to strengthen future regulatory strategies. + Ensures consistent interpretation and application of regulatory policies across project teams. **Minimum Qualifications** + Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related scientific discipline. + Advanced degree (Master’s or equivalent) strongly preferred. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com