Senior Regulatory Affairs Consultant – Regulatory Project Manager

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

📋 Description

• Collaborate strategically with Global Regulatory Leads to develop and implement forward-thinking, globally synchronized regulatory plans throughout all phases of development and post-marketing.

• Convert regulatory strategies into cohesive, actionable plans featuring clear milestones, critical paths, risks, and opportunities to facilitate effective planning and decision-making.

• Oversee the implementation of regulatory plans, ensuring that daily operations align with broader strategic goals across global programs.

• Identify and recommend innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives.

• Work closely with cross-functional teams and senior leadership to ensure clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies.

• Lead Global Regulatory Subteam (GRST) meetings and other regular and ad hoc project review forums, ensuring that meetings are purposeful, well-organized, and focused on decision-making, risk management, and regulatory execution.

• Anticipate and address complex regulatory project and operational challenges, implementing scalable solutions that enhance team effectiveness, process efficiency, and submission readiness.

• Prepare and present strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights.

⛳️ Requirements

• A BA/BS degree in a scientific, engineering, or healthcare discipline is required.

• At least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with a minimum of 5 years in regulatory or regulatory program management.

• Demonstrated ability to collaborate on regulatory strategies and lead execution across all phases of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.

• In-depth understanding of U.S. and EU regulatory requirements, along with a working knowledge of global regulations and agency expectations.

• Proven success in managing complex regulatory deliverables across cross-functional teams within a matrixed organization while maintaining alignment with strategic priorities.

• Practical experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategies.

• Excellent communication and influencing skills, with the capability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders.

• Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight.

• Proven ability to utilize project management tools and best practices to improve visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams.

🏝️ Benefits

• Health insurance

• Flexible work arrangements