Regulatory Manager – Senior Regulatory Manager

🔥 1 minute ago

🇵🇱 Poland – Remote

💵 zł190.2k - zł285.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 9%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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 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 documents, and marketing applications • Provide strategic regulatory input as required • Develop and 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, 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 • Maintain and execute 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 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), including submissions to Regulatory Authorities, 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 and interpret clinical and pre-clinical study results for regulatory positions and strategy • Knowledge of clinical trials methodology, 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 and maintain good records • Ability to work and plan independently and in a team environment • Ability to motivate project team members to meet timelines and goals • Ability to resolve project-related problems and prioritize workload with little management support • Ability to communicate effectively in English, verbally and in writing • Proficiency conducting formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

• Discretionary annual bonus • Private medical insurance • MultiSport Card • Life insurance • Pension • Home working allowance • Vacation • Other benefits • Reasonable accommodation for applicants with disabilities