Regulatory and Start Up Specialist/ Senior Regulatory and Start Up Speciali at Precision Medicine Group

, , Belgium -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Clinical Trials, Site Activation, Clinical Trial Application, Project Management, Communication, Organizational Skills, Data Management, Translation Coordination, Patient Information Sheet, Informed Consent Form, Regulatory Intelligence, Budget Negotiation, Feasibility Assessment, Audit Readiness, Essential Document Review

Industry

Pharmaceutical Manufacturing

Description

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. As our organisation continues to grow we are hiring a Regulatory and Start Up Specialist/ Senior Regulatory and Start Up Specialist to join our team in Belgium or The Netherlands. This position can be only offered fully home based. 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 for Belgium and The Netherlands. 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 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. Experience /Qualifications 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. 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. 1 year or more in part II submissions for clinical trials in Belgium and/or Netherlands 1 year or more for ICF country adaptation for Belgium and/or Netherlands 1 year or more in site level documents collection for submissions and IP release for Belgium and/or Netherlands Regulatory/ SU experience for covering Belgium and the Netherland Fluency in Dutch and English Fluency in French is a plus Other Required: Strong communication and organizational skills. Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. Preferred: 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. We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. #LI-EK1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. 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 QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Responsibilities

The specialist is responsible for ensuring site activation readiness in Belgium and the Netherlands, preparing clinical trial application forms, and interacting with regulatory authorities. They will also maintain project plans and provide updates on submissions to the project team.