Regulatory Manager – Senior Regulatory Manager

🔥 0 minutes ago

🇸🇰 Slovakia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures • Ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations • Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees • Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications • Provide strategic regulatory input as required • Develop and/or review submission documents for Regulatory Authorities and Ethics Committees • Represent Global Regulatory Affairs at project team meetings with external and internal customers • Work within project teams and lead regional or global projects when necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated • Assist in developing Regulatory Affairs Specialists and other operational staff • Provide input into regulatory strategy and timeline development for new study opportunities • Assist in establishing company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients • Represent Global Regulatory Affairs at business development meetings

🎯 Requirements

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years of regulatory experience required for the Manager level • 7 years of regulatory experience required for the Senior Manager Regulatory level • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialized knowledge of regulatory activities for at least one major region (EU or US) • Experience working in regulatory affairs for a CRO or within the Pharmaceutical Industry • Experience leading Clinical Submissions • Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy • Knowledge of clinical trials methodology, including working knowledge of protocols and indications being studied • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel, including overnight stays • Strong interpersonal skills and ability to contribute to a team environment • Understanding of financial management • Ability to manage multiple varied tasks in a fast-moving environment • Good record-keeping skills • Ability to work and plan independently and in a team environment • Ability to motivate project team members to meet timelines and project goals • Flexible attitude toward work assignments and new learning • Ability to resolve project-related problems and prioritize workload with little management support • Focus on continuous improvement and process efficiency • Ability to collect consistently high-standard data • Effective verbal and written English communication skills • Ability to conduct formal presentations proficiently to colleagues, investigative staff, and clients

🏖️ Benefits

• Employees feel appreciated for their contributions • Employee ideas are valued and nurtured • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities