Sr. Regulatory Affairs Manager

Katalyst CRO; Baltimore (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading Clinical Research Organization in Baltimore is seeking a Regulatory Manager to provide strategic regulatory guidance for clinical trials and ensure timely submissions to regulatory authorities. The ideal candidate will have at least 7 years of regulatory experience, specifically in leading clinical submissions. Strong interpersonal skills and the ability to manage multiple tasks in a dynamic environment are essential for success in this role. This position offers an opportunity to work collaboratively on innovative clinical projects.

Qualifications

• 7 years of regulatory experience required.
• Experience in Clinical Research Organisation and leading submissions.
• Knowledge of regulatory activities in major regions (EU, US).

Responsibilities

• Provide regulatory strategy and guidance for clinical trials.
• Prepare regulatory documents for submission to authorities.
• Maintain knowledge of regulations and provide analysis to project teams.
• Develop documents for submission to the Regulatory Authorities.

Skills

Regulatory experience

Interpersonal skills

Understanding of drug development

Teamwork

Problem-solving

Education

Bachelor's degree in a scientific or healthcare discipline

Job description

Overview

The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures, 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. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function. 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, paediatric 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. Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy. Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development. Availability for domestic and international travel including overnight stays. Motivates other members of the project team to meet timelines and project goals. Flexible attitude with respect to work assignments, and new learning. Resolves project related problems and prioritize workload to meet deadlines with little support from management. Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective. Collects data of consistently high standard. Communicates effectively in the English language both verbally and in written form. Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.

Responsibilities

• The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures, 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
• The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function
• 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, paediatric 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
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
• Availability for domestic and international travel including overnight stays.
• Motivates other members of the project team to meet timelines and project goals
• Flexible attitude with respect to work assignments, and new learning.
• Resolves project related problems and prioritize workload to meet deadlines with little support from management.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
• Collects data of consistently high standard.
• Communicates effectively in the English language both verbally and in written form.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.

Requirements

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
• 7 years Regulatory experience required for the Senior Manager Regulatory level.
• Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions.
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and 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.
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities.
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates.
• Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills.
• Exhibits high self-motivation and can work and plan independently as well as in a team environment.