Remote Regulatory affairs Jobs

Responsible for managing the preparation, quality control, publishing, dispatch, and archival of all regulatory submissions within the Veeva RIM system. Oversees the regulatory submission process for all assigned projects and products throughout their lifecycle. Provides training and guidance to regulatory staff on Veeva RIM functionality and best practices.

• Prepare and compile regulatory dossiers for international markets.
• Coordinate and review administrative and technical documentation for new product registrations.
• Manage regulatory documents and data within Veeva Vault RIM.

• Lead the strategy and execution of regulatory and quality frameworks.
• Oversee regulatory submissions, including 510(k) and De Novo.
• Ensure compliance with FDA, ISO 13485, and MDR.

• Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
• Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
• Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.

• Support the management of crop protection product registration dossiers under EU Regulation 1107/2009.
• Review regulatory dossiers to ensure compliance with client quality standards and EU requirements.
• Lead planning, submission, and post-submission activities for new formulations and product renewal programs.

• Develop and update compliance templates, policies, checklists, competency assessments, and other related resources.
• Research, interpret, and link federal and state regulations, accreditation standards, and evidence-based practices to MedTrainer solutions.
• Create and maintain compliance documents, ensuring accuracy, consistency, and adherence to formatting and metadata standards.

The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. As the internal subject matter expert on FDA regulations of prescription drug advertising and promotion, this role collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives. The incumbent will serve as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP).

As Clinical Lead in Scotland, you will foster the relationship between Big Health UK and NHS teams in Scotland, working with stakeholders to ensure the clinical delivery of Big Health treatments in the NHS is effective and aligned with priorities. You will champion digital therapeutics and be a point of escalation for clinical safety issues, reporting to the UK Medical Director in this part-time role.

This role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership.

The Senior Manager will lead strategic operations across cosmetics and chemicals regulatory services, supporting global clients in achieving compliance across EU, UK, and US markets. This role will oversee cross-functional teams, manage client relationships, and drive innovation in regulatory and IT-enabled service delivery.