LGC Genomics GmbH
LGC is a global leader in the life sciences sector, serving customers in healthcare, applied markets (including food, agbio and the environment), academia and government. Underpinned by our five core values - integrity, brilliance, passion, curiosity, respect - our core purpose is to deliver science for a safer world. To strengthen our team, we're seeking homebased in Germany a Global Regulatory Affairs and Compliance Director (m/f/d) Job Description Job Purpose: The Global Director, Regulatory Affairs and Compliance is a strategic position within the Genomics Division of LGC that provides regulatory leadership and support of LGC's globally expanding CE-IVD product portfolio and research and development funnel. This leader serves as a key member of multi-disciplinary project teams, and must be able to evaluate potential commercial opportunities, acting on various complex scenarios involving expansion or development of novel in-vitro diagnostic (IVD) products and programs, and manage to challenging and evolving timelines. The successful candidate bears responsibility for determination and implementation of applicable regulatory strategies required to ensure global compliance. Besides wide regulatory affairs expertise in IVD's, the successful Global Regulatory Affairs and Compliance Director candidate provides mentorship and management of teams and change, able to work across all organization levels, boundaries, and geographic regions with functional leaders including executive management, in a complex matrix environment to: Ensure the accurate and timely preparation of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs or LGC commercial products. Coordinate with MHRA, FDA and other regulatory agencies in connection with submission, approvals, and inspections. Participate in joint Strategy, Product Marketing and Project teams as the senior representative of regulatory affairs in the Genomics division. Primary Duties and Responsibilities: Prepare and present regulatory affairs project status reports, strategy and initiatives to Genomics leadership teams, Sr. Management staff, and teams. Oversee and participate, as appropriate, in preparation of company regulatory submissions, site master files, as needed. Work closely with cross-functional teams providing regulatory oversight and guidance to regulatory compliance matters, and MHRA, FDA or other competent authority requirements. May provide regulatory perspective on clinical trial and / or oversight on product stability test designs to ensure endpoints support customer approval and acceptance. Keep abreast of global IVD guidance, regulations and timelines, especially those relevant to the Genomics' product portfolio. Certify conformity to regulatory standards and participate in the review and approval of customer-facing or marketing documentation, including, but not limited to Website material, product labeling including, User Manuals, Certificates / Declarations of Conformity, animal origin statements and/or product hazard analysis. Formulates regulatory processes / procedures and shares best practices / knowledge with quality and regulatory colleagues. Create corporate templates for Technical Files, Declarations of Conformity, Risk Documents to assist process owners, customer service, marketing and sales teams in maintaining and improving the accuracy and effectiveness of customer-facing regulatory documents. Review critical regulatory communications and evaluate conformance with the regulatory requirements, clarity, and completeness. Proactively monitor and plan for changes that affect Genomics statutory and regulatory requirements in alignment with leadership and functional area teams. Track, collate, and report global Regulatory metrics, including adverse events and any post market surveillance trends. This position requires travel and time away from the office. Travel out of the area typically involves overnight stays. Qualifications Education: PhD or PharmD in a scientific discipline along with at least 7 years of industry relevant experience or BS/MS with a minimum of 10 years of increasingly responsible regulatory experience in the lifesciences or biopharmaceutical industry. Regulatory Affairs Certificate (RAC) in Medical Device, Pharmaceutical or dual certificate is highly desirable. Knowledge: Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development of drug substance or drug products in multiple ICH regions. Deep familiarity with IVD global regulations and guidelines, specifically EU IVD regulations, US 21 CFR 803, 806, 809, 820, 864, CLIA '88 and ISO 15198. Expertise with global regulatory strategies, including direct experience in pharmaceutical, medical device and / or in vitro diagnostic clinical and product applications. Understanding of ISO 13485:2016 and/or MDSAP and Part 820 / 210 / 211 quality system regulations, incorporation of ISO 14971 or ICH Q9 Risk Management principles, and application of ICH Q6 is a plus. Certificates, Licenses, and Registrations and Training: ISO 13485:2016 Auditor or Lead Auditor certification a plus RAPS member is preferred Skills: Proven record of effective collaboration with regulatory agencies (e.g., MHRA, FDA, MPA, ANVISA, etc.). Strong influencing capability combined with excellent written and oral communications skills. Evaluative, risk-based, analytical and interpretative skills enabling review of documents or synthesis of reports used in regulatory planning. Work autonomously and effectively to set priorities to meet timelines, motivate others, and manage to budgetary requirements. Demonstrated risk based application and approach, problem solving and strategizing capabilities. Ability to proactively identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks. Our contribution to our long-term relationship: Working in a global team A pleasant working environment with regulated working hours Modern structures and a friendly team A varied field of action permanent contract Professional and personal development opportunities Company pension scheme 30 days annual leave cycle to work scheme Is the chemistry right? If you have the professional and personal elements for a connection with LGC, we look forward to your online application via our career portal, stating your earliest possible start date and your salary expectations.
Pharma, Chemie, Med.-/ Biotechnologie
Projekt- und Produktmanagement/ Qualitätsmanagement
Vorstand/ Geschäftsführung/ Unternehmensführung
Bereichs-/ Abteilungs-/ Gruppenleitung