Direct, manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.
Manage Regulatory and Start-up (RSU) team(s) and overall activities, where applicable.
Provide Regulatory and Start-Up expertise and / or technical consultancy on a variety of projects;
Determine expectations and parameters for operations and provides senior review and guidance for most documents prepared by colleagues
Oversee the execution of Country Regulatory & Start Up and / or Maintenance for assigned projects in accordance with the agreed RSU strategy
Review and analyze site performance metrics and processes to provide input in the development and implementation of process / system improvements, where applicable.
May be assigned to local / regional / global process improvement working groups.
Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
Where applicable, act as a Country Lead for projects with no regional / global Lead assigned.
Collaborate and communicate across departments to successfully deliver the agreed project scope in compliance with the agreed project plans and procedures.
Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Ensure overall project efficiency and adherence to project timelines and financial goals; report project and site performance metrics and out of scope activities as required.
Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
Perform pre-award activities including attendance at bid defense and sales meetings and support with material / presentations, review of proposals and oversight of the scope of work at country level.
May provide input into contract and budget template development.
Work with Quality Management to ensure appropriate quality standards for the duration of the project.
Identify and make recommendations to resolve ongoing training and development needs of staff, where applicable; prepare and deliver country-specific training for less experienced staff and mentor and coach colleagues as required.
May deliver presentations / training to clients and professional bodies, as required.
May act as Local Regulatory and Contract Expert; may participate in feasibility and / or site identification activities.
May perform Site Selection Visits if trained as a monitor.
May undertake line management responsibilities, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good negotiating and communication skills with ability to challenge
Good interpersonal skills, a strong team player
Good regulatory and / or technical writing skills
Thorough understanding of regulated clinical trial environment and knowledge of drug development process
Proven ability to exercise independent judgment taking calculated risks when making decisions
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Good presentation skills
Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines
Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
Excellent understanding of study financial management
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent.
At least 1 years’ relevant experience Regulatory and Start-Up experience (local submissions submitting local clinical studies) or equivalent combination of education, training and experience.
Fluent in English
Excellent interpersonal skills