Regulatory Affairs Associate Director – EU Regulatory Lead

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🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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