Regulatory and Start-Up Specialist

Summary

Join Precision Medicine Group as a Regulatory and Start Up Specialist (RSS) and contribute to the success of clinical trials. You will be responsible for site activation readiness, preparing and submitting clinical trial applications, interacting with regulatory authorities, maintaining project plans, and ensuring compliance with regulations. This role requires a Bachelor's degree in life sciences or a related field, 1+ years of experience in regulatory or site start-up, strong communication and organizational skills, and fluency in English and the local language of the country where the position is based. Preferred qualifications include relevant regulatory and site start-up experience for the specific country, experience using milestone tracking tools, and an advanced degree in medical or life sciences. This position offers a competitive salary, annual bonus, health insurance, retirement savings benefits, life and disability insurance, parental leave, and paid time off.

Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Strong communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and for non-English speaking countries the local language of country where position based
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Strong organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments, and new learning
• Occasional travel may be required

Responsibilities

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration
• Prepare. review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and  other required reviews to secure on time site activation for the assigned sites in the country
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits
• May support process improvement initiatives, training, and mentoring
• Performs other duties as assigned by management

Preferred Qualifications

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country
• Experience using milestone tracking tools/systems
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Benefits

This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits