Remote Regulatory affairs Jobs · Regulatory Affairs

• 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.

• 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.

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.

The Senior Specialist, Regulatory and PV Network is responsible for developing regulatory strategy, driving regulatory and PV deliverables, and serving as a liaison between regulatory and other functional areas, including external partners and clients. They will act as Local Contact Person for Pharmacovigilance, manage projects, provide strategic input, and ensure compliance with regulatory requirements.

Lead and execute the regulatory strategy for CAR T programs, serving as the primary regulatory representative, guiding activities across preclinical, clinical, and manufacturing stages, partnering with internal teams and external partners. Work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. The ideal candidate brings experience in Regulatory Affairs within a clinical-stage biotech.

Provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.