Regulatory Manager
Precision Medicine Group, Peapack, NJ, United States
Position Summary
The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well‑organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable, and maintains a current knowledge of regulations and guidance documents, providing analysis to project teams and supporting Precision for Medicines’ corporate Regulatory function.
Essential Functions
Provides regulatory guidance throughout the clinical development life cycle
Compiles, coordinates and reviews applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications, and 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
Serves as a representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads projects for the region or globally
Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintains project plans, trackers and regulatory intelligence tools as related to assigned responsibilities and keeps Regulatory Leadership updated
Assists in development of Regulatory Affairs Specialists and other operational staff as required
Provides input into regulatory strategy and timeline development for new study opportunities and assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing corporate quality initiatives across business units within clinical solutions
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serves as a representative of Global Regulatory Affairs at business development meetings
Qualifications
Minimum Required:
Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
Computer literacy (MS Office/Office 365)
Fluent in English
Preferred:
Graduate or postgraduate education
Basic understanding of financial management
Other Required:
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), including submissions to Regulatory Authorities, INDs/CTAs, amendments, Scientific Advice Procedures and post‑approval submissions
Ability to understand clinical and pre‑clinical study results to aid in regulatory positioning and strategy
Knowledgeable of clinical trials methodology, including 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
Competencies
Strong interpersonal skills and proven ability to contribute to a team environment involving multifaceted research activities
Demonstrates professionalism – punctuality, reliability, service culture and positive interactions with customers and teammates
Ability to manage multiple tasks in a fast‑moving environment with good record‑keeping skills
Exhibits high self‑motivation and ability to work independently and in a team
Motivates other team members to meet timelines and project goals
Flexible attitude toward work assignments and new learning
Resolves project‑related problems and prioritizes workload to meet deadlines with limited management support
Focuses on continuous improvement and proactively seeks efficiencies in processes and people
Collects data consistently of high standard
Communicates verbally and in written form effectively
Conducts formal presentations to a wide variety of audiences with high proficiency
Compensation & Benefits
Reasonable estimate of the current range: $106,000 USD – $151,000 USD. The role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off including sick leave and vacation.
Equal Opportunity Employer
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
#J-18808-Ljbffr
The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well‑organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable, and maintains a current knowledge of regulations and guidance documents, providing analysis to project teams and supporting Precision for Medicines’ corporate Regulatory function.
Essential Functions
Provides regulatory guidance throughout the clinical development life cycle
Compiles, coordinates and reviews applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications, and 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
Serves as a representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads projects for the region or globally
Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintains project plans, trackers and regulatory intelligence tools as related to assigned responsibilities and keeps Regulatory Leadership updated
Assists in development of Regulatory Affairs Specialists and other operational staff as required
Provides input into regulatory strategy and timeline development for new study opportunities and assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing corporate quality initiatives across business units within clinical solutions
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serves as a representative of Global Regulatory Affairs at business development meetings
Qualifications
Minimum Required:
Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
Computer literacy (MS Office/Office 365)
Fluent in English
Preferred:
Graduate or postgraduate education
Basic understanding of financial management
Other Required:
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), including submissions to Regulatory Authorities, INDs/CTAs, amendments, Scientific Advice Procedures and post‑approval submissions
Ability to understand clinical and pre‑clinical study results to aid in regulatory positioning and strategy
Knowledgeable of clinical trials methodology, including 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
Competencies
Strong interpersonal skills and proven ability to contribute to a team environment involving multifaceted research activities
Demonstrates professionalism – punctuality, reliability, service culture and positive interactions with customers and teammates
Ability to manage multiple tasks in a fast‑moving environment with good record‑keeping skills
Exhibits high self‑motivation and ability to work independently and in a team
Motivates other team members to meet timelines and project goals
Flexible attitude toward work assignments and new learning
Resolves project‑related problems and prioritizes workload to meet deadlines with limited management support
Focuses on continuous improvement and proactively seeks efficiencies in processes and people
Collects data consistently of high standard
Communicates verbally and in written form effectively
Conducts formal presentations to a wide variety of audiences with high proficiency
Compensation & Benefits
Reasonable estimate of the current range: $106,000 USD – $151,000 USD. The role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off including sick leave and vacation.
Equal Opportunity Employer
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
#J-18808-Ljbffr