Regulatory Manager

Summary

Join Precision for Medicines as a Regulatory Manager and provide regulatory development advice and guidance for clinical trials. You will ensure timely preparation of quality regulatory submissions, coordinate and prepare regulatory documents for submission to authorities and ethics committees, and maintain current knowledge of regulations. Responsibilities include providing regulatory guidance throughout the clinical development lifecycle, compiling and reviewing applications to regulatory authorities, developing and reviewing submission documents, and serving as a representative of Global Regulatory Affairs. You will also oversee and coordinate Regulatory Affairs Specialists, maintain project plans, and assist in the development of staff. The role requires a Bachelor's degree or equivalent experience, 5+ years of relevant experience, and specialized knowledge of regulatory activities. Preferred qualifications include a graduate degree and a basic understanding of financial management. Competitive compensation and benefits are offered.

Requirements

• 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

Responsibilities

• Provide 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
• P rovide 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

Preferred Qualifications

• 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