This position can be fully remote PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily
Job Description Job Description Job Description We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting services.
About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of
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The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable
About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC RA representative, work with brands
Job Description Job Description Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio
Associate Director, Regulatory Strategy Inozyme Pharma is searching for an Associate Director, Regulatory Strategy to join their growing Regulatory Affairs team. As an Associate Director, Regulatory Strategy, this individual will be responsible for guiding regulatory strategy and leading global health authority interactions to support global
Department Description: Mammalian Purification Process Development, part of the Sanofi R&D CMC organization, is responsible for development, scale-up, transfer, and characterization of purification processes for clinical and commercial manufacturing of therapeutic proteins from the mammalian production
About the Department Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the
Intertek Scientific and Regulatory Consultancy Group is looking for a motivated and client focused senior regulatory affairs professional who is seeking an opportunity to be a Program Manager to promote our food, nutrition and regulatory consulting services. The Principal Scientist/Associate Director
Job Description: Principal, UX Developer As a Principal, UX Developer on the Creative Solutions team, you get excited about solving challenges while working in a collaborative team environment. Bringing stories to life through thoughtful UX and
Job Description Job Description Company Description Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomeds Patients First! culture drives our skilled
Job Description Job Description As a Clinical Research Associate you will serve as the pivotal link between clinical studies and robust clinical data. You’ll lead efforts to identify, evaluate, and establish clinical study sites for in-vitro diagnostic
Job Description Job Description Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor
Job Description Job Description Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely
Job Description Job Description Job Description About This Role The Associate Director, Marketing, Patient Engagement, Rare Disease - Friedreichs ataxia(FA) position will be a critical role and visible leader within the North American Organization leading the overall
Job Description Job Description Company Description Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell
Location: Lexington office. Hybrid schedule: 4 days in-office, 1 day remote. As the Associate Director of Quality Assurance GMP, reporting to the Executive Director, Quality, youll manage GMP quality standards for clinical-stage programs. This includes overseeing production