(Sr.) Regulatory Affairs Director REMOTE - EUROPE
Multiple Locations: United Kingdom • Poland • France • Germany • Italy • Spain
Requisition Number: 3116
Position Title: Director, Regulatory Affairs
SUMMARY: Accountable for senior-level leadership in establishing the operational strategy and achieving high performance and growth objectives for global regulatory affairs. Reports to Senior Vice President, Site Activation and Regulatory Affairs. This role has project-specific dotted line reporting to the Site Activation Therapeutic Leads.
- Oversees the delivery and performance of regulatory affairs activities and supporting roles such as Regulatory Affairs Managers and Regulatory Affairs Specialists.
- Provides expert regulatory advice and contributes to regulatory project work for internal and external customers
- Provides and drives the overall planning and oversight for regulatory affairs activities including high quality and timely delivery for internal and external stakeholders and projects
- Responsible for regulatory affairs-related in business development activities by attending key Proposal Strategy Meetings (e.g., Executive and Strategic level), contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, essential document activities and other country and/or project-specific activities for regulatory affairs in support of the overall site activation strategy
- Stays currently informed as a subject matter expert of changing regulatory affairs requirements and ensures the regulatory affairs group is proactively trained as current subject matter experts in their local area and/or other relevant areas of expertise for their role
- Remains current and knowledgeable with SOPs, ICH GCP and regulatory and quality regulations as applicable and is accountable for the compliance with SOPs, ICH GCP and regulatory and quality regulations of the regulatory affairs group
- Fosters professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
- Responsible for the preparation of technical /master study documentation in accordance to the study requirements, contracted scope and specific legislations
- Accountable for the performance and development of Regulatory Affairs Managers and Regulatory Specialists to ensure critical path activities are completed on time and ensures optimal start and conduction of regulatory affairs activities to meet project deliverables
- Establishes processes and standards for financial growth and operational continuous improvement.
- Ensures high quality performance of deliverables are applied within the projects assigned to line reports and promptly identify and address any risk/potential risk by implementing preventive measures and mitigation plans
- Provides expert regulatory knowledge with the Site Activation functional leads and the rest of project team to establish risk mitigation strategies/contingency plans and present these to sponsors
- Manages regulatory affairs team workload and provides input for allocations etc. according to demand (including holidays approval and proper back-up)
- Builds, develops, coaches and leads a team of direct reports responsible for regulatory affairs activities globally
- May attend customer facing meetings related including Governance, bid defense, and escalation
- Participates in the development and maintenance of departmental processes, tools, policies, SOPs and associated documents.
- Assists the Site Activation leadership team and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary
OTHER SKILLS AND ABILITIES:
- Strong oral and written communication skills to clearly and concisely interpret and present information
- Strong and proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
- Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint, regulatory portals and Worldwide applications
- Expert understanding of clinical research principles and processes
- Demonstrated ability to independently manage multiple tasks in a fast-paced and changing environment while delivering in an organized, methodical and self-motivated manner to solve complex and time sensitive problems
- Excellent interpersonal skills in a fast-paced, deadline oriented, and changing environment
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
- Minimum 10 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
- Proficient in cross-cultural communication and proficient in both spoken and written English
Employment Type: Regular
Community / Marketing Title: (Sr.) Regulatory Affairs Director REMOTE - EUROPE
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Rome, IT