The Head of Regulatory Affairs will be the first Regulatory person in my clients organisation whose key purpose is to set the strategy and then build out the team. This person shall work closely with and assist in providing regulatory intelligence support, strategic regulatory advice, compiling regulatory submission packages and executing submissions to regulatory agencies […]
Read moreMy client is seeking a Director of Regulatory Affairs to lead regulatory strategy and the company’s interactions with the FDA and other regulatory agencies. She/he will work closely with our scientific team and external advisors to build relationships with those agencies, help guide the development team to meeting the requirements for advancing therapeutic candidates into […]
Read moreYour Responsibilities Provide regulatory affairs CMC strategy guidance to support integrated projects throughout the entire development lifecycle. Lead and drive global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects, namely INDs/BLAs/MAAs applications including scientific and technical review for accuracy, soundness, and regulatory app...
Read moreI am partnered with a Global Service provider, performing quality management reviews and CE certifications for medical device manufacturers around the world. They are a global leader ensuring the latest innovations in medical technology reach the patients whilst ensuring they are safe for patients and health workers. This is an opportunity to join an organisation […]
Read moreOur client is a small Medical Device manufacturer based in Tuttlingen. They are looking to strengthen their RA & QA department to keep all new and existing medical device products compliant with the new MDR as well as bringing new innovative products to market. The role will cover products in all lifecycle stages, from early […]
Read moreAbout – Here at Scienta we are teaming up with a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. The QC ...
Read moreCompany Our client is an international medical device manufacturer focused on bringing innovative solutions to market, giving millions of patients access to the best care and healthier living. This is a fantastic opportunity to expand your career in a high growth business, where your unique skills are valued. They are looking for a Site Head […]
Read moreOur client is a international Medical Device company focused on innovation and digitisation, they are also a market leader with a well-established reputation in their field. Their mission is bringing cutting edge technology to market, giving millions of hospitals and laboratories access to the best equipment and facilitate their research and healthcare capabilities. This is […]
Read moreSr. Manager/ Associate Director Regulatory CMC – Small Molecule Want to join a Global Pharmaceutical leader? This client is a Global Bio-pharmaceutical Company focused on delivering high quality treatments to patients. They have a robust pipeline of development products and 9 commercial stage assets. Responsibilities: Provide regulatory strategic and/or operational support for Small-Molec...
Read moreMy client is a listed clinical phase biotechnology looking for a strong & established Head of Regulatory to join their growing organisation. As a Head of Regulatory you will have the following responsibilities: Provide leadership and hands on management of Regulatory Affairs their clinical and preclinical development portfolio, including CMC. You will work as the […]
Read morePosition Responsibilities Participate on project development teams and represent regulatory affairs by supporting project and product teams. Prepare regulatory submissions as required for global approvals for in vitro diagnostic (IVD) products, including preparation of reports and interaction with regulatory officials as required. Prepare and submit to notified body Technical Documentation need...
Read moreHead of Regulatory Affairs Want to join a growing biotech? This is a great opportunity for a Senior Regulatory expert to lead regulatory at Clinical Stage Immunology focused company. This client is seeking a hands-on head of Regulatory Affairs who will bring broad experience in regulatory affairs and operations along with a roll up the […]
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