Regulatory Manager – Senior Regulatory Manager

🔥 1 hour ago

🇷🇴 Romania – 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 throughout clinical trials • Guide regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures • Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees • Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications • Develop and/or review submission documents to ensure compliance with regulatory standards • Represent Global Regulatory Affairs at project team and business development meetings with internal and external 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 • Contribute to 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

🎯 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 required for the Senior Manager 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 and 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 trial 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 • Understanding of financial management • Ability to manage multiple and varied tasks in a fast-moving environment • Good record-keeping skills • Ability to work and plan independently and in a team environment • Ability to resolve project-related problems and prioritize workload to meet deadlines • Ability to collect data of consistently high standard • Effective verbal and written communication in English • Proficiency conducting formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

• The posting states that employees feel appreciated for their contributions • Employee ideas are valued and nurtured, with opportunities to impact positive change • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities