Regulatory and Start Up Specialist

Precision Medicine Group; Madrid; On-site; EUR 60,000 - 90,000; Full time

Job summary

Precision for Medicine in Spain is seeking a Regulatory and Start Up Specialist to join our growing team. The role focuses on regulatory submissions, start-up activities, and budget/contract negotiations for Spain.

The ideal candidate will have strong experience with CA/EC submissions, site activation, and working within CRO or biotech environments, as well as fluency in English and Spanish.

Qualifications

• Bachelor's degree in life sciences or related field.
• RN or equivalent combination of education, training and experience.
• Demonstrated experience in contracts and budgeting negotiation for Spain.

Responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers for CA/EC and local bodies.
• Coordinate with CA/EC for submissions and responses.
• Maintain project plans, trackers and regulatory intelligence tools for assigned studies.
• Develop start-up plans, IMP release requirements and essential document review criteria.
• Partner with sites and ensure alignment for site activation and budget negotiations.
• Coordinate translations of site documents and maintain TMF readiness.
• Keep updated on local clinical trial laws and distribute knowledge within PFM.

Skills

Communication skills

Organizational skills

English and Spanish fluency

Portuguese knowledge (a strong plus)

Education

Bachelor's degree in life sciences

RN or equivalent

Pharmacy/ Pharmacist experience

Advanced degree in medical or life sciences / RAC

Job description

Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. Apart from the experience with regulatory submissions, for this role it's key for candidates to have contracts and budgeting negotiation experience for Spain.

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

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, 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
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• 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
• Review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up 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.

Minimum Required

• 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.
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience in contracts and budgeting negotiation experience.

Other Required

• Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and Spanish, fluency in Portuguese would be a strong plus.

Preferred

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.
• 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.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].