Clinical Trial Regulatory Manager

**Job Title**:Clinical Trial Regulatory Manager**

**Job Location**: Europe (homebased)

**Job Overview**:
**Job Duties and Responsibilities**:

- Act as a SSU lead for the assigned countries and regions participating directly at kick-off meetings, sponsor calls providing the client with procedural and legal guidance, and study updates and advice as how to respond to IRB/EC and CA/MOH questions and requests.
- Prepare the forecast of all SSU intermediate steps and oversee the execution in order to achieve contractual milestones.
- Manage the Country Specialists appointed to the project and ensuring they are included as doing SSU work on the project list linked to the QA SOP system (ensure compliance to the SSU SOP’s for those specialists who might have multiple roles) as well as ensure the country specialists have the SSU/regulatory project training appointed in the project training list for the project.
- Manage all country specific requests for the CTA/CTAA having the overview as to when and how these requests should be fulfilled as well as the implication including these documents, and whether PM acceptance and sponsor approvals should be obtained.
- Is responsible for the performance of the reporting project team, escalating issues to the appropriate Line Manager.
- Participate (limited) in RFI/RFP processes, bid defenses, initial business development meetings with prospective clients, proposal development, and other business development activities as requested.
- Demonstrate flexibility, patience, strong attention to details and leadership by example.
- Confidently operate in electronic databases and systems such as electronic Trial Master Files, time recording, authority and IRB/EC electronic document upload and submission systems.
- May be called upon to conduct trainings

**Supervisory Responsibilities**:
No supervisory responsibilities.

**Job Requirements**:

- Education
- A minimum of Bachelor of Science in life sciences, pharmacist, M.Sc. or Doctorate in sciences preferred.
- Experience
- A minimum of 5 years working in start-up/regulatory affairs for clinical trials (preferably; the experience might also have been obtained working in quality assurance, manufacturing or with regulatory affairs for clinical product, marketed medicinal products or medical devices depending on the combined experience), including minimum 1 year of proven leadership experience in the leading or supporting role
- Experience with biologics and ATMPs are preferable.
- Experience and understanding of pharmaceutical manufacturing and/or clinical project management is an advantage.
- Recent SSU experience participating actively in the projects (CTA/CTAA) in the region of employment, including initial CTA, is required preferably in a service vendor like a Clinical Research Organization (CRO).
- Working knowledge of regulations: Has expertise to work in accordance to local guidelines (provided by SSU groups in each country) on local projects. Is aware of, and consults guidelines, and adhere to them on a project specific basis.
- Skills/Competencies
- Analytical: be able to identify and understand SSU issues in an early phase for the clinical trial and concisely convey the issue to the internal and client project team as well as draft a response to resolve the issue understanding the urgency. Ability to problem solve and work independently using own initiative
- Concise communication: speaks clearly, listens and react calmly, and is persuasive in positive or negative situations to ensure the efficient conduct of meetings; able to identify, extract and describe issues in short and accurately in writing. Ability to establish effective relationships with sponsors and internal team member
- Quality Management: proactively suggests quality improvements to procedures, electronic systems to promote accuracy and compliance.
- Sound judgment: displays willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
- Planning/Organizing - Prioritizes and plans work activities, uses time efficiently and develops realistic action plans. Demonstrates flexibility and willingness to learn new skills that are relevant to the position.
- Capabilities
- Windows; proficient in MS Word, Excel, Power point.
- Experienced in utilizing regulatory intelligence databases.
- Excellent organizational skills.
- Exceptional English written and oral communication skills, proficiency in other language is an advantage
- Excellent personal interaction skills
- Excellent team player.

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The company will not accept unsolicited resumes from third party vendors.