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.
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.
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.
Conduct thorough evaluations of new ingredients and technologies for potential use in products.
Propose ingredients or technologies and dosages that can deliver against the intended consumer end-benefit.
Synthesize scientific research and translate into substantiated claims/benefits for dietary supplements.
Nutrafol pioneers hair wellness, creating clinically tested products for hair growth and support at every journey step. With a multifactorial approach, they target key root causes using a patented blend, recommended by over 7,500 physicians and hair professionals.
Providing strategy based on regulatory requirements.
Completing regulatory and PV deliverables based on established plan.
Acting as Local Contact Person for Pharmacovigilance for designated country.
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 and value employee experience, well-being and mental health.
Accountable for the regulatory inventory, regulatory compliance products library for Pismo and DPS Products.
Monitor regulatory environments assisting your product teams in finding and understanding changes in regulations through new legislation, changes in guidance and examiners' manuals.
Working with Product on new and improved features and products research and identify regulations, review them for applicability by working with product, legal, and others.
Pismo, founded in 2016, provides a comprehensive processing platform for banking, card issuing and financial market infrastructure. With 500+ employees across 10 countries, they help clients innovate and transition from legacy systems to advanced technology, maintaining high security and availability standards.
Collaborate with Country Directors to shape the regional commercial plan.
Oversee growth and management of marketing efforts in the Thailand region.
Monitor key performance indicators and pinpoint avenues for enhancement.
JustMarkets is a leading player in the financial industry, committed to empowering traders and partners with cutting-edge tools and personalized services. As they expand their global presence, they're seeking talented individuals and fostering a collaborative environment.
Lead regulatory compliance across 10 APAC markets.
Monitor regulatory developments in the payments and fintech landscape.
Design and execute licensing strategies across key jurisdictions.
Xplor provides cloud-based technology solutions for small and medium-sized businesses, enabling them to manage their operations. They aim to help businesses get paid quickly and securely. Xplor has a global network of talented colleagues.
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.
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.
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 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.
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.
Review course scripts, slides, and assessments for accuracy and regulatory alignment
Identify outdated, missing, or unclear content
Flag technical inaccuracies or misinterpretations of regulations
EasyLlama is transforming the HR compliance industry by reinventing outdated and uninspiring training solutions. They boast a 96% rating on G2 from over 100 reviews and have earned the trust of over 5,000 clients, fostering a culture of collaboration, innovation, and getting things done.
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.
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.
Lead all phases of regional partner programs to enable the delivery of exceptional learning experiences for students.
Building and maintaining positive and productive relationships with partner stakeholders including institutional leaders, administrators, and instructors.
Managing processes, workstreams, project timelines, and reporting across the partnership.
Minerva Project collaborates with educational institutions, nonprofits, governments, and corporations to design and implement transformational educational programs. They are an experienced group of academics, designers, and higher education experts, who are passionate about student-centered learning and believe that institutions need to transform in order to better serve the needs of humanity.
Be instrumental in driving Axolabs’ sales in the US and Asia and in extending brand recognition within the associated client base.
Deliver bespoke solutions to meet client requirements drawing on a sound scientific background in life sciences.
Proactively engage with new and existing clients to close deals and forge alliances.
Axolabs specializes in oligonucleotide or nucleic acid therapeutics, using their expertise to help clients succeed in this field. They believe in Science for a Safer World and are seeking candidates for their high-growth organization with locations in Petaluma, US, Kulmbach, and Berlin, Germany.
Design, implement and lead the dietary residue strategy for the development and registration of new active ingredients/products.
Collaborate with the Study Monitor and Analytical Teams to drive the deliverables and design for residue studies.
Create and implement strategies to address emerging issues and opportunities in North America.
Syngenta Crop Protection keeps plants safe from planting to harvesting, helping farmers counter threats and ensure enough safe, nutritious, affordable food while minimizing land use. The company is headquartered in Switzerland, fostering a culture that celebrates belonging and collaboration, promotes professional development and strives for work-life balance.
Part of the Veeva Development Team within the Information System organization.
System administrator in the Veeva Quality and Regulatory systems.
Hands-on role combining system administration, configuration, solution design, and system evolution within the Veeva Development Cloud ecosystem.
Sobi redefines the standards of care and transforms the lives of people living with rare diseases. They are a diverse team of entrepreneurial people, with over 1,900 employees in more than 30 countries, passionate about growth towards becoming a global leader.