Regulatory Manager

March 21

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Precision For Medicine

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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.

Global Clinical Trial Services • Specialty Lab Services • Translational Science • Clinical Data Management • Biostatistics

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

📋 Description

• The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials • The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities • The RM maintains a current knowledge of regulations and guidance documents • Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team and leads where necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintains project plans and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists • Provide input into regulatory strategy and timeline development • Participates in maintaining and executing corporate quality initiatives • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development • Provides ICH GCP guidance to internal and external clients • Serves as representative of Global Regulatory Affairs at business development meetings

🎯 Requirements

• Bachelors degree or equivalent experience in a scientific or healthcare discipline • Computer literacy (MS Office/ Office 365) • Fluent in English • 5+ years of relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones • Specialized knowledge of regulatory activities for at least one major region (EU, US) • Ability to understand clinical and pre-clinical study results for regulatory positions • Knowledgeable of clinical trials methodology • Knowledge and expertise with relevant regulations and guidelines • Availability for domestic and international travel including overnight stays

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation