Regulatory Information Manager

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

📋 Description

• Collaborate with the regulatory team to support all activities related to document management.

• Assist in the implementation and upkeep of the Regulatory Information Management System across all programs.

• Archive documents related to regulatory submissions, content plans, and health authority inquiries for efficient searching and retrieval.

• Oversee and maintain document repositories, trackers, and dashboards, ensuring that accurate and up-to-date information is available as a communication tool within R&D.

• Author departmental documents, including Standard Operating Procedures (SOPs), to support the systems and processes utilized in Regulatory Affairs and Regulatory Development Plans.

• Contribute to departmental initiatives, including the development of processes and infrastructure, regulatory intelligence, and budgeting.

⛳️ Requirements

• Bachelor's degree in a scientific field with 2-3 years of experience in the Pharma/Biotech industry.

• Proven strong organizational skills and a self-motivated attitude.

• A mindset geared towards project management.

• Ability and willingness to learn new technologies and software.

• Capability to work efficiently in a fast-paced, collaborative, and dynamic environment.

• Experience in a Regulatory Affairs department is a plus.

• Previous experience with Veeva RIM is an advantage.

• Strong interpersonal skills with the ability to work collaboratively with subject matter experts.

• Proven problem-solving skills, adaptability, and teamwork.

• Excellent communication, writing, and presentation abilities.

• Advanced proficiency in MS Office, Adobe Pro, and Smartsheet.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.

• Flexible work arrangements.