Regulatory Manager – Senior Regulatory Manager

🔥 7 minutes ago

🇷🇸 Serbia – 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 • 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 meetings, orphan designations, paediatric planning, and marketing applications • Provide strategic regulatory input as required • Develop and/or review submission documents to ensure compliance with regulatory standards • 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; update Regulatory Leadership • 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 and 7 years 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 with submissions to Regulatory Authorities, including INDs/CTAs, amendments, Scientific Advice Procedures, and post-approval submissions • Regulatory affairs experience working 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 and team-environment skills • Understanding of financial management • Ability to manage multiple varied tasks in a fast-moving environment and maintain good records • Ability to work and plan independently and in a team environment • Ability to resolve project-related problems and prioritize workload with little management support • Effective verbal and written communication in English • Ability to conduct formal presentations proficiently to colleagues, investigative staff, and clients

🏖️ Benefits

• Regular full-time employment • Remote work arrangement • Opportunity to join a growing global team • Employee contributions valued and nurtured • Opportunity to impact positive change for the company