Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Prepare, verify, check and approve product specifications to meet client requirements and service level agreements.
Provide technical and regulatory support and advice to clients and internal/external parties.
Deliver technical compliance projects and ensure areas of responsibility meet agreed KPIs.
SGS is the world's leading testing, inspection and certification company, renowned for quality and integrity. Its 100,000 employees work across 2,600 offices and laboratories to enable a safer, more interconnected world.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Provide technical and regulatory support to Compliance Managers and Senior Advisors, ensuring product documentation meets client policies.
Prepare, verify, check, and approve product documentation using supplier information, reporting any non-compliance.
Apply client's new and updated policies, regulatory, and technical requirements; maintain awareness of microbiology and nutritional analysis.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 100,000 employees operating across 2,600 offices and laboratories, SGS fosters a culture of trust, reliability, and innovation to enable a better, safer, and more interconnected world.
Provide professional regulatory consultancy to key retail clients, ensuring product safety and legal compliance.
Prepare and check pack copy, approve artwork, and ensure compliance with food labelling legislation.
Maintain technical competence and stay up to date with UK and EU legislation and industry trends.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for quality and integrity. With 100,000 employees across 2,600 offices and laboratories, we help ensure food safety, quality and compliance through our Food industry services.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Conduct toxicological risk assessments and impurity qualification for pharmaceutical and consumer health products.
Author and review toxicology modules for regulatory submissions, including CTD/eCTD dossiers.
Monitor evolving global regulations and provide scientific justification for safety assessments.
WNS is an Agentic AI-powered leader in intelligent operations and transformation, serving over 700 clients across 10 industries. With more than 66,000 employees across 13 countries, the company combines deep domain expertise with AI-powered platforms to deliver sustainable outcomes.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.