- 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.
- 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.
- 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.
- 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.
- 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.
- Participate in Health Authority meetings, representing company regulatory strategy with clarity, confidence, and scientific rigor.
- Serve as the primary RA representative for in‑licensing opportunities, independently evaluating regulatory risks, feasibility, and integration pathways.
- 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.
- 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.
- Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related scientific discipline.
- Advanced degree (Master’s or equivalent) strongly preferred.
Salarisomschrijving
€70000 - €100000 monthly