Regulatory Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $106k - $151k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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 development advice and guidance throughout the clinical development life cycle • Compile, coordinate, and review applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications • Develop and/or review documents for submission to Regulatory Authorities and Ethics Committees • Represent Global Regulatory Affairs at project team and business development 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 • Help establish 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 • Computer literacy with MS Office/Office 365 • Fluent in English • 5+ years of relevant regulatory affairs experience • 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 INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions • Ability to understand and interpret clinical and pre-clinical study results for regulatory positions and strategy • Knowledge of clinical-trial methodology, including working knowledge of protocols and studied indications • 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 • 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 to meet deadlines with little management support • Ability to conduct formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

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