Senior Regulatory and Start Up Specialist (Mexico)

precisionmedicinegroup; México; On-site; MXN 1,200,000 - 1,800,000; Full time

Job summary

Precision for Medicine is expanding across Mexico and Latin America and seeks a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico. You will oversee regulatory submissions, site activation activities, essential document management, and ensure compliance with local and international trial regulations.

As a seasoned professional, you will train staff, support budget/contract negotiation with Site Contract Management, and collaborate with cross-functional teams to drive efficient

Qualifications

• Bachelor's degree in life sciences or related field.
• Experience in regulatory submissions and site start-up is a plus.

Responsibilities

• Delivery of site activation readiness within the assigned country/sites, ensuring timely and quality results.
• Prepare Clinical Trial Application Forms and submission dossiers for CA, EC, and local bodies within required timelines.
• Interact with CA/EC and provide timely responses and updates to stakeholders.
• Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
• Support development of country start-up plans, IMP release requirements, and essential document review.
• Partner with site CRA to align communications and secure site collaboration.
• Translate and coordinate translations for submission documents as needed.
• Maintain knowledge of local trial laws and ensure compliance with international and local regulations.
• Maintain TMF readiness and file documents per TMF plans.

Education

Bachelor's degree in life sciences or related field

Job description

We're expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we're hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico !

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• 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 Competent Authorities (CA) , Ethics Committee (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
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine 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 participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

• Minimum Required: Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or