Regulatory Project Manager – Contract

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

📋 Description

• Oversee and manage global regulatory affairs advertising and promotion initiatives and portfolios.

• Ensure alignment of GRA-AP projects and portfolios with organizational goals and timelines.

• Develop and establish regulatory project management frameworks, tools, and best practices.

• Provide strategic guidance for projects and portfolios.

• Facilitate communication among regulatory affairs, project teams, stakeholders, and external collaborators.

• Monitor project progress, materials, and deliverables; identify and address issues.

• Lead and attend regulatory project meetings.

• Record meeting minutes, update project portals, and communicate results.

• Perform administrative tasks to support project teams and departmental operations.

• Assist in ensuring efficient and compliant regulatory submissions and initiatives that advance corporate objectives.

• Take on additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline, regulatory affairs, project management, or a related field.

• A minimum of 3 years of experience in regulatory project management within the pharmaceutical or biotechnology industry, or a similar combination of education and experience.

• Experience in managing cross-functional project teams.

• Capability to establish project management frameworks, articulate procedures, and drive regulatory advertising and promotion compliance efforts.

• Exceptional written and verbal communication skills, along with stakeholder engagement, briefing, and influencing abilities.

• Strong organizational, analytical, and problem-solving skills, with an emphasis on continuous improvement.

• Proficient in project and knowledge management software and methodologies.

• Advanced computer skills, including the Microsoft suite, OneDrive, SharePoint, and regulatory platforms such as Veeva.

• Ability to work independently and with moderate supervision while juggling competing priorities across multiple projects.

• Preferred familiarity with monitoring and ensuring adherence to regulatory standards, guidelines, and submission requirements.

🏝️ Benefits

• Eligible for overtime pay in accordance with federal and state regulations.

• Compensation, medical benefits, fringe benefits, and other terms and conditions of employment will be detailed by the third-party agency partner upon offer.