Remote Regulatory affairs Jobs · Communication

• 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.

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).

Responsible for the delivery of site activation readiness and mitigating any risks. Preparation of Clinical Trial Application Forms and submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to requirements. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Maintenance of project plans, project trackers and regulatory intelligence tools. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.