Regulatory Project Manager (Contract)

Vertex Pharmaceuticals LLC; United States; On-site; USD 110,000 - 117,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Regulatory Project Manager to lead and coordinate global GRA-AP projects, ensuring alignment with corporate objectives and timelines.

You will guide cross-functional teams, enable compliant regulatory submissions, and drive process improvements to support Vertex’s growing pipeline. This temporary role involves collaboration with an external agency to deliver strategic regulatory advertising and promotion initiatives.

Qualifications

• Bachelor’s degree in a scientific discipline, regulatory affairs, project management, or related field.
• Minimum 3 years’ experience in regulatory project management within the pharmaceutical or biotechnology industry.
• Experience managing cross-functional project teams and driving compliance initiatives.
• Excellent written and verbal communication with proven stakeholder engagement.

Responsibilities

• Lead and coordinate global regulatory advertising and promotion projects.
• Track project progress, materials, and deliverables; proactively resolve issues to maintain momentum.
• Lead regulatory project meetings; document minutes, update portals, and communicate outcomes to stakeholders.
• Provide administrative support to project teams and department operations.

Skills

Regulatory PM frameworks

Cross-functional leadership

Stakeholder communication

Regulatory advertising & promotion

Project tracking & reporting

Meeting facilitation

Administrative support

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

Microsoft Office Suite (SharePoint/OneDrive)

Job description

Job Description

General Position Summary: The Regulatory Project Manager is responsible for leading and coordinating global regulatory affairs advertising and promotion (GRA-AP) projects and portfolios in alignment with organizational objectives. This role plays a critical part in advancing GRA-AP outreach and process enhancement priorities, ensuring strategic oversight, and building capabilities to serve growing business needs. The manager will provide expert guidance across cross-functional teams and projects to enable efficient and compliant regulatory submissions and support initiatives to drive support for corporate goals.

Required Knowledge & Skills

• Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness.
• Provide strategic oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines.
• Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution.
• Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum.
• Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders.
• Perform administrative functions to support project teams and department operations.
• Assume additional duties as assigned to ensure regulatory project and portfolio success.

Required Experience & Education

• Bachelor’s degree in a scientific discipline, regulatory affairs, project management, or a related field
• Minimum of 3 years’ experience in regulatory project management within the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience.
• Experience managing and cross-functional project teams is essential.
• Demonstrated ability to build project management frameworks, explain procedures, and drive regulatory advertising and promotion compliance initiatives.
• Excellent communicator, both written and verbal, with proven stakeholder engagement, strong briefing, and influencing skills.
• Strong organizational, analytical, and problem-solving skills, with a focus on continuous improvement.
• Proficient in project and knowledge management software and techniques.
• Advanced computer skills to support and maintain department software (e.g., Microsoft platform, OneDrive, SharePoint), and regulatory platforms (e.g., Veeva).
• Ability to work independently and under moderate supervision, managing competing priorities across several projects.
• Preferred familiarity with monitoring and ensuring compliance with regulatory standards, guidelines, and submission requirements.

Pay Range $80-$85/HR

temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”).