Regulatory Affairs Associate Director – EU Regulatory Lead

• Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities
• Guide filing strategy and coordinate disciplines to ensure timely filings with EMA and applicable EMEA agencies
• Oversee regulatory affairs vendors involved in marketing authorization filings
• Contribute hands-on to regulatory filings and related activities
• Provide regulatory leadership for post-approval activities
• Monitor, interpret and communicate changes to the global regulatory landscape
• Serve as regulatory affairs business partner to local commercialization teams
• Partner with medical, legal, quality, PV and distribution teams on regulatory input for business decisions
• Connect assigned project-team strategy with broader global regulatory and development teams
• Lead review and provide technical advice for regional and global regulatory submissions
• Provide regulatory strategy advice and technical expertise to internal and external clients
• Oversee key client projects and ensure quality performance
• Manage project budgeting and forecasting
• Identify out-of-scope contract activities and coordinate contract modifications
• Collaborate with business development on pricing, new business presentations, proposals and budgets
• Oversee matrix/project leadership, training and guidance for junior team members
• Ensure compliance with organizational and departmental SOPs and WPDs
• Participate in and lead launch, review and project-team meetings
• Lead departmental initiatives and project teams
• Liaise with local country regulatory authorities and clients
• Travel occasionally to domestic and international sites

• Advanced degree required; PhD or PharmD strongly preferred
• Comparable to 12+ years of experience; minimum 10 years’ experience in regulatory affairs within pharmaceutical organizations
• Strong emphasis on EMA regulatory frameworks
• At least one end-to-end regulatory submission process, preferably with the centralised procedure
• Experience in rapidly growing pharmaceutical organizations advantageous
• Thorough understanding of the drug development lifecycle
• Demonstrated expertise in orphan drug development
• Knowledge of the global regulatory landscape, particularly Europe, Switzerland, the UK, Israel and the Middle East
• Ability to lead and coordinate critical regulatory documents for medicinal product approval and lifecycle management, including EU regulatory strategy and PIPs
• Track record of successful engagement with regulatory and health authorities
• Mastery of English language, written and oral, and local language where applicable
• Exceptional attention to detail, quality, editorial and proofreading skills
• Advanced computer skills, including Microsoft Word, Excel and PowerPoint
• Organizational, time management and planning skills
• Professional negotiation skills
• Ability to work independently and exercise independent judgment
• Advanced understanding of regulatory requirements and procedures for clinical trial authorization, licensing and lifecycle management
• Expert knowledge of ICH and other global regulatory guidelines
• In-depth understanding of regulatory specialty areas such as preclinical, clinical, CMC and publishing
• Advanced understanding of medical terminology, statistical concepts and guidelines
• Analytical, investigative and problem-solving skills
• Understanding of budgeting and forecasting
• Executive presence, consultation and presentation skills
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered

• Fully remote work arrangement
• Standard Monday–Friday work schedule