Job
Description
Position Overview: The Project Manager will play a critical role in managing and overseeing regulatory projects and initiatives across global markets. This position will be responsible for ensuring the timely and efficient management of regulatory submissions, maintaining compliance with relevant regulations, and working closely with cross-functional teams to drive global regulatory strategies for product approvals. Key Responsibilities: Global Project Leadership: Lead and manage the global regulatory project lifecycle for product submissions, ensuring alignment across multiple regions and compliance with local regulatory requirements. Develop detailed project plans, define timelines, allocate resources, and monitor the progress of regulatory activities across markets. Act as the primary point of contact for internal and external stakeholders, ensuring clear communication, and managing expectations throughout the project lifecycle. Data Analytics: Prepare reports and dashboards to visualize regulatory data and provide actionable insights to support decision-making. Collaborate with regulatory affairs teams to identify trends, bottlenecks, and opportunities for process optimization. Ensure data accuracy and integrity across regulatory databases and systems. Regulatory Strategy Development: Collaborate with senior regulatory leaders to develop and implement global regulatory strategies tailored to each market, ensuring timely approvals and compliance with regulatory standards. Provide expert guidance on regulatory pathways, requirements, and timelines to ensure smooth submissions and minimize delays. Cross-functional Collaboration: Partner with R&D, clinical, commercial, and legal teams to ensure product development aligns with regulatory requirements. Coordinate and manage interactions with regulatory agencies, ensuring timely responses to inquiries and ensuring a strong relationship with regulatory authorities. Lead cross-functional teams through regulatory milestones, ensuring that all stakeholders are aligned and informed. Regulatory Submissions & Approvals: Oversee the preparation and submission of regulatory filings, including INDs, NDAs, CTDs, and other regulatory documents, ensuring they are accurate, complete, and meet regulatory standards. Manage the submission process and monitor progress until approvals are granted, ensuring timely responses to any regulatory questions or requests for additional information. Risk Management & Problem Solving: Identify potential regulatory and project risks and develop mitigation strategies to proactively address challenges. Troubleshoot issues related to regulatory compliance, submissions, or product approvals, providing timely solutions to keep projects on track. Maintain up-to-date knowledge of industry trends, regulatory changes, and emerging issues that could impact the projects progress. Regulatory Intelligence & Continuous Improvement: Monitor and analyse global regulatory trends and provide guidance on evolving regulations in target markets. Share insights on regulatory best practices and contribute to the development of internal processes, templates, and tools to improve efficiency in regulatory project management. Proactively suggest improvements in workflows to streamline processes and ensure continuous improvement within the regulatory function. Stakeholder Reporting & Communication: Provide regular updates and reports on the status of regulatory projects, including timelines, milestones, risks, and progress to senior leadership and key stakeholders. Prepare and deliver presentations to senior management, providing clarity on regulatory project status and risk assessments. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's or advanced degree preferred). Minimum 5-7 years of experience in regulatory affairs or project management in the pharmaceutical, biotechnology, or medical device industries. Experience with data analysis, data visualization tools (e.g., Excel, Tableau, Power BI), and familiarity with regulatory affairs processes. Proven track record of managing complex global regulatory projects, including submissions and approvals. Certification in Project Management (e.g., PMP) or Regulatory Affairs (e.g., RAC) is a plus. Experience with global regulatory submissions in multiple regions (e.g., FDA, EMA, ICH guidelines).
