Provide legal counsel to Sales, Marketing, Medical Affairs, advising on regulatory matters.
Participate in MLR Review Committees and advise on advertising and scientific exchange.
Ensure compliance with laws, regulations, policies, procedures, and controls.
Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are expanding their presence and searching for high-impact individuals to strengthen their team.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Develop annual marketing plans, brand strategies, and value propositions for DT120
Manage the entire product lifecycle from pre-launch to post-launch, including market assessment, segmentation, and differentiation, execution, measurement, and optimization
Drive digital strategy, including Veeva systems, social media, and web initiatives to engage Healthcare Professionals (HCPs) and patients
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding our presence and global footprint with a team of patient-centric, intelligent individuals.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.
Preparation and submission of regulatory dossiers.
Advise on strategies and registration requirements for product development and marketed products.
Lead regulatory assessment and actions for changes to product and QMS processes.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. They have more than 10,000 colleagues and provide products and services in around 90 countries, promising to be forever caring.
Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.