Business Services & Consulting • all cities, MT 27
Accountable for senior-level leadership in establishing the operational strategy and achieving high performance and growth objectives for global regulatory affairs. Reports to Senior Vice President, Site Activation and Regulatory Affairs. This rolehas project-specific dotted line reporting to the Site Activation Therapeutic Leads.
Oversees the delivery and performance of regulatory affairs activities and supporting roles such as Regulatory Affairs Managers and Regulatory Affairs Specialists.
Provides expert regulatory advice and contributes to regulatory project work for internal and external customers
Provides and drives the overall planning and oversight for regulatory affairs activities including high quality and timely delivery for internal and external stakeholders and projects
Responsible for regulatory affairs-related in business development activities by attending key Proposal Strategy Meetings (e.g., Executive and Strategic level), contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, essential document activities and other country and/or project-specific activities for regulatory affairs in support of the overall site activation strategy
Stays currently informed as a subject matter expert of changing regulatory affairs requirements and ensures the regulatory affairs group is proactively trained as current subject matter experts in their local area and/or other relevant areas of expertise for their role
Remains current and knowledgeable with SOPs, ICH GCP and regulatory and quality regulations as applicable and is accountable for the compliance with SOPs, ICH GCP and regulatory and quality regulations of the regulatory affairs group
Fosters professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
Responsible for the preparation of technical /master study documentation in accordance to the study requirements, contracted scope and specific legislations
Accountable for the performance and development of Regulatory Affairs Managers and Regulatory Specialists to ensure critical path activities are completed on time and ensures optimal start and conduction of regulatory affairs activities to meet project deliverables
Ensures high quality performance of deliverables are applied within the projects assigned to line reports and promptly identify and address any risk/potential risk by implementing preventive measures and mitigation plans
Provides expert regulatory knowledge with the Site Activation functional leads and the rest of project team to establish risk mitigation strategies/contingency plans and present these to sponsors
Manages regulatory affairs team workload and provides input for allocations etc. according to demand (including holidays approval and proper back-up)
Builds, develops, coaches and leads a team of direct reports responsible for regulatory affairs activities globally
May attend customer facing meetings related including Governance, bid defense, and escalation
Participates in the development and maintenance of departmental processes, tools, policies, SOPs and associated documents.
Assists the Site Activation leadership team and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary
Strong oral and written communication skills to clearly and concisely interpret and present information
Strong and proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint, regulatory portals and Worldwide applications
Expert understanding of clinical research principles and processes
Demonstrated ability to independently manage multiple tasks in a fast-paced and changing environment while delivering in an organized, methodical and self-motivated manner to solve complex and time sensitive problems
Excellent interpersonal skills in a fast-paced, deadline oriented, and changing environment
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years' experience within clinical research (e.g. CRA, Reg Affairs.)
Minimum 10 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
Proficient in cross-cultural communication and proficient in both spoken and written English
Accountable for senior-level leadership in establishing the operational strategy and achieving high performance and growth objectives for global regulatory affairs. Reports to Senior Vice President, Site Activation and Regulatory Affairs. This rolehas project-specific dotted line reporting to the Site Activation Therapeutic Leads.
Oversees the delivery and performance of regulatory affairs activities and supporting roles such as Regulatory Affairs Managers and Regulatory Affairs Specialists.
Provides expert regulatory advice and contributes to regulatory project work for internal and external customers
Provides and drives the overall planning and oversight for regulatory affairs activities including high quality and timely delivery for internal and external stakeholders and projects
Responsible for regulatory affairs-related in business development activities by attending key Proposal Strategy Meetings (e.g., Executive and Strategic level), contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, essential document activities and other country and/or project-specific activities for regulatory affairs in support of the overall site activation strategy
Stays currently informed as a subject matter expert of changing regulatory affairs requirements and ensures the regulatory affairs group is proactively trained as current subject matter experts in their local area and/or other relevant areas of expertise for their role
Remains current and knowledgeable with SOPs, ICH GCP and regulatory and quality regulations as applicable and is accountable for the compliance with SOPs, ICH GCP and regulatory and quality regulations of the regulatory affairs group
Fosters professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
Responsible for the preparation of technical /master study documentation in accordance to the study requirements, contracted scope and specific legislations
Accountable for the performance and development of Regulatory Affairs Managers and Regulatory Specialists to ensure critical path activities are completed on time and ensures optimal start and conduction of regulatory affairs activities to meet project deliverables
Ensures high quality performance of deliverables are applied within the projects assigned to line reports and promptly identify and address any risk/potential risk by implementing preventive measures and mitigation plans
Provides expert regulatory knowledge with the Site Activation functional leads and the rest of project team to establish risk mitigation strategies/contingency plans and present these to sponsors
Manages regulatory affairs team workload and provides input for allocations etc. according to demand (including holidays approval and proper back-up)
Builds, develops, coaches and leads a team of direct reports responsible for regulatory affairs activities globally
May attend customer facing meetings related including Governance, bid defense, and escalation
Participates in the development and maintenance of departmental processes, tools, policies, SOPs and associated documents.
Assists the Site Activation leadership team and/or other company departments in leading or participating in department initiatives, tasks forces, and additional training where necessary
Strong oral and written communication skills to clearly and concisely interpret and present information
Strong and proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint, regulatory portals and Worldwide applications
Expert understanding of clinical research principles and processes
Demonstrated ability to independently manage multiple tasks in a fast-paced and changing environment while delivering in an organized, methodical and self-motivated manner to solve complex and time sensitive problems
Excellent interpersonal skills in a fast-paced, deadline oriented, and changing environment
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years' experience within clinical research (e.g. CRA, Reg Affairs.)
Minimum 10 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
Proficient in cross-cultural communication and proficient in both spoken and written English
