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 firstname.lastname@example.org.
For more information you can contact Ronald van der Geest on +31 (0)13 5348272.
Acquisition is not appreciated!
Consultant Regulatory CMC
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 Regulatory Chemistry Manufacturing and Control (CMC). As a CMC Regulatory consultant you will be working in a multi-disciplinary team and will be responsible for giving the team (incl. e.g. the CMC lead; process development rep, analytical rep) regulatory guidance and direction in order to finally arrive at a dossier that will meet regulatory expectations. The CMC Reg consultant must be able to both help develop CMC regulatory strategies as well as be hands on and deliver regulatory documentation related to CMC, including e.g. comparability protocols, submission documents such as IND, IMPD, etcetera.
• MSc or PhD in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
• At least 5 years of experience in a comparable position and/or work environment is preferred
• Essential communication skills: fluency in English, oral, written and presentation skills
• Extensive experience in writing documents for regulatory purposes
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients
In addition, we expect a Consultant Regulatory CMC to meet at least some of the following requirements;
• Demonstrated competency, experience, and knowledge on CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry
• Preferred experience with both small molecules and biologicals
• Experience with agency interactions
• Experience in project coordination and project team participation
Interested? Send your CV and short motivation letter to 3D-PharmXchange at email@example.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated