3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Candidates should have an extensive and proven track record within companies developing innovative drugs (small molecules/biologicals/novel therapies), with a focus on early stage drug development.
We offer a challenging job in an international environment, working for top entrepreneurs and big pharma. You will be working in a very dynamic, young and growing team and you will have freedom to shape your work.
3D-PharmXchange does not accept unsolicited resumes from any third-party recruiters or agencies. Acquisition is also not appreciated
Consultant Regulatory Affairs
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and the Pivot Park in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts aims to cover the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.
For the development of the various projects we run for our clients, we are looking for a regulatory affairs expert with at least 7 years experience in global regulatory affairs, who is able to look beyond his or her borders and has an ambition to grow in a young and growing organization.
Requirements & roles
• Knowledge of and experience in global regulatory requirements (including CMC) for the development and registration of new medicinal products (chemical entities and biologicals)
• Knowledge and experience in CMC regulatory affairs is a pre
• Experience in preparation and submission of clinical trial applications
• Experience in preparing regulatory strategies for all stages of drug development
• Experience in writing and reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, CMC, nonclinical and clinical dossier (eCTD) overviews/summaries, DSURs/PSURs, pre-IND/End-of-Phase 2/scientific advice briefing/background packages, target product profiles, product information/labeling documents, risk management plans (RMPs), agency response documents, etc.
• Experience in preparation and submission of scientific advice and orphan designation applications and peadiatric investigational plans (PIPs)
• Experience in companion diagnostic regulations is a pre
• Experience in contacts and meetings with regulatory agencies
• Project coordination and project team participation
• Demonstrated competency and experience in all stages of drug development within the pharmaceutical industry
• Essential communication skills: good oral, writing and presentation skills
• Essential personality skills: pro-active, team player, entrepreneurial, can work under time pressure, can-do mentality and ability to put yourself in the position of our clients.
Interested? Send your CV and short motivation letter to 3D-PharmXchange at email@example.com.
For more information you can contact Ronald van der Geest on +31 (0)13 5348272.
Acquisition is not appreciated!
Consultant Clinical Development
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.
For the various projects that we are running for our clients, we are looking for a consultant Clinical Development.
As a consultant, you will be responsible for the development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
• Responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria
• Being able to translate biomarker data to decisive proof-of-concept studies
• Responsible for the design, execution and reporting of clinical trials according to timelines and within budget
• Responsible for the writing of essential documents e.g. Clinical Trial Protocol, IB etc.
• A clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
• A clinical representative in a cross functional collaborative environment.
• An equal and expert discussion partner in the communication with KOL’s
• Managing external partners/service providers
• Guiding operational clinical activities
• Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients
• Relevant academic background in biomedical field, preferably PhD
• Experience with (early) clinical drug development
• A minimum of 5 years’ experience in the biotech or pharmaceutical industry;
• Evidence of good scientific and clinical judgment, flexibility, and resilience
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines;
• Experience with Scientific Advice meetings at EMA or FDA is a pre.
• Well-developed organizational talent
• Strong sense of meeting milestones, timelines & budgets
• Excellent communication and presentation skills
• Excellent writing skills (English)
• Ability to work independently and in a team environment
• Capable of effectively managing multiple deadlines and projects
• Ability to adapt to rapidly evolving situations and needs
• Strong commitment to delivering high-quality work
• Strong interpersonal and communication skills to drive results in a cross functional collaborative environment.
Interested? Send your CV and short motivation letter to 3D-PharmXchange at firstname.lastname@example.org. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated