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.
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.
Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Responsible for shaping the program's cross-functional vision, strategic context, and lifecycle plan (LCP) for both current and future business opportunities.
Ensures timely delivery and manages the associated execution plan and milestones, closely aligning them with the approved LCP.
Facilitates clear decision-making by incorporating cross-functional input to address high-impact issues and co-creating solutions to complex challenges in real time.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors and they are committed to continuous innovation in cell therapy, including gene-edited cell therapy.
Liaise with regulatory authorities on technical/regulatory questions.
Provide technical expertise to the global Medical Devices network.
Manage the team of IVDR product assessors and IVDR IHC.
SGS stands as the world's foremost testing, inspection, and certification company, recognized globally for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we foster a dynamic, international culture committed to high professional standards and long-term employee development.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Lead strategic planning and execution of Medical Affairs initiatives aligned with corporate objectives.
Drive operational excellence through process improvement, change management, and performance tracking.
Partner with cross-functional stakeholders to ensure seamless integration of medical strategies.
Kardigan is a heart health company working to make cardiovascular disease preventable and curable. They're driven by patients and their families, deeply committed to improving lives and prioritizing patient needs, authentic, always learning, winning as a team, and enabling the impossible.
Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
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.
Design, implement, and maintain the firm’s written compliance policies and procedures.
Conduct an annual review of the adequacy of the firm’s compliance policies and procedures.
Identify and assess regulatory risks across all business activities.
Kraken builds the future of crypto with a world-class team united by the desire to unlock the potential of crypto and blockchain technology. It is a fully remote company with Krakenites in 70+ countries and is committed to industry-leading security and crypto education.
Lead regulatory compliance projects from initiation through completion.
Interpret new and evolving regulations and translate them into actionable project plans.
Oversee regulatory audits, assessments, and remediation activities.
SGS is the global leader in inspection, verification, testing and certification services. With over 97,000 employees in 130 countries, they provide services to almost every industry assuring quality and safety of products and services, fostering innovation and welcoming new ideas.
Partner with product and marketing teams to ensure compliance with consumer protection regulations.
Monitor and analyze new and evolving regulatory requirements, assessing their impact on products.
Manage and develop a team of compliance professionals by setting clear expectations.
EarnIn is a pioneer of earned wage access, building products that deliver real-time financial flexibility for those with the unique needs of living paycheck to paycheck. It is a fast-growing company with experienced leadership and world-class funding partners.
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.
Prepare regulatory filings, conduct routine audits, and organize documentation for legal reviews.
Collaborate with attorneys and business leaders to support compliance initiatives and respond to regulatory inquiries.
Provide guidance to internal stakeholders on compliance requirements.
AffirmedRx aims to improve healthcare outcomes by bringing clarity, integrity, and trust to pharmacy benefit management. They are committed to making pharmacy benefits easy to understand, straightforward to access, and always in the best interest of employers. and the lives they impact.
Supports compliance initiatives through data analysis and process improvement.
Develops and executes strategic business objectives supporting key business areas.
Develops training on compliance and privacy topics.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Their aim is to make personalized genetic testing and diagnostics part of the standard of care. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for their work and each other.
Research, interpret and advise on SEC and SRO rules.
Draft and submit rule changes and amendments with the SEC.
Work directly on regulatory examinations and lead LTSEs responses.
The Long-Term Stock Exchange (LTSE) is an SEC-registered national securities exchange designed to promote fair and orderly markets, as well as help long-term focused companies get the credit they deserve. LTSE works with companies to identify long-term investors that will value their efforts to prioritize sustainable, long-term growth.
Lead efforts to shape medical strategy and planning on one or more key accounts.
Educate creative, strategy, editorial, and account teams on medical and scientific aspects of assigned accounts.
Review patient or HCP promotional materials to assure scientific accuracy and strategic alignment.
Avalere Health is a consulting firm focused on healthcare. They work with pharmaceutical companies and other healthcare organizations providing strategic advice. The company fosters a collaborative and innovative culture.
Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR).
Partner closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams.
Help build and strengthen Docplanner's regulatory framework, directly supporting EU MDR compliance and global expansion.
Docplanner Group's mission is to help people live longer, healthier lives. As the world’s largest healthcare platform, they connect 24 million patients with 280k doctors across 13 countries. Docplanner's marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently.
Serves as the OFP’s principal advisor and center of expertise on federal and other government funding.
Offers enterprise-level insight on the federal landscape, regulatory changes, risk/benefit considerations, and strategic options.
Develops policies, procedures, training, and tools that strengthen readiness for government funding.
The American Heart Association is dedicated to fighting cardiovascular diseases and stroke. With over a century of trusted leadership, they drive breakthroughs in science, policy, and care for healthier people and communities.