Precision Medicine Group ยท 1 day ago
Regulatory Manager
United States
Full-time
Remote
Mid, Senior Level
$106K/yr - $151K/yr
5+ years expPrecision Medicine Group is focused on providing regulatory development advice for clinical trials. The Regulatory Manager will ensure timely preparation of regulatory submissions and maintain compliance with applicable regulations while supporting the corporate Regulatory function.
BiotechnologyHealth Care
Responsibilities
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings
Qualification
Required
Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
Computer literacy (MS Office/ Office 365)
Fluent in English
5 + years or more 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) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledgeable of clinical trials methodology, including a 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
Preferred
Graduate, postgraduate
Possesses basic understanding of financial management
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase