Regulatory Consultant, CMC-EU, GCC, AU

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct research on existing product data in relation to global or regional regulatory requirements to prepare gap analyses, product development plans, and various regulatory submissions.

• Contribute to or create both administrative and technical components for submissions to regulatory agencies.

• Oversee and/or implement the daily regulatory activities for assigned projects, adhering to established timelines and scope.

• Act as regulatory support within multidisciplinary project teams throughout the product development life cycle.

• Serve as a subject matter expert to assist team members with everyday troubleshooting tasks.

• Develop estimates for regulatory services as part of proposals.

• Ensure adherence to global regulatory standards and company policies.

• Create training materials and disseminate best practices within the regulatory field.

⛳️ Requirements

• Experience in researching existing product data concerning global or regional regulatory requirements.

• Expertise in preparing both administrative and technical elements of regulatory agency submissions.

• Capability to manage and operationalize the execution of regulatory activities for assigned projects.

• Experience working within multidisciplinary project teams focused on product development.

• Strong presentation skills to effectively communicate solutions to project-related challenges.

• Experience in preparing estimates for regulatory service execution.

• Familiarity with compliance to relevant global regulatory standards and company processes.

• Involvement in internal or external project audits and support for internal cross-functional initiatives.

🏝️ Benefits

• We are dedicated to the growth of our employees through career development and advancement opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.

• Driven to Deliver, reflecting our colleagues' passion to show up daily and create solutions that can significantly impact lives.