Global Regulatory Submission Planning Sr. Manager – Obesity

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

📋 Description

• Act as the regulatory product planning leader for a prominent obesity asset, ensuring a cohesive understanding of regulatory priorities, milestones, dependencies, and risks across various indications.

• Create and uphold a detailed Regulatory Product Plan that aligns regulatory goals and activities, health authority engagements, development milestones, and key business priorities.

• Collaborate with Global Regulatory Leads (GRLs), regional regulatory leads, and representatives from regulatory functions to foster alignment on crucial deliverables, timelines, risks, and execution strategies.

• Establish and sustain visibility into essential regulatory milestones, guaranteeing that leadership possesses a clear grasp of readiness, risks, dependencies, and potential impacts on regulatory goals.

• Organize regulatory planning forums to facilitate decision-making, resolve issues, and proactively manage emerging regulatory challenges.

⛳️ Requirements

• Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience.

• At least 2 years of experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• Experience in supporting global regulatory activities within obesity, cardiometabolic, or similar therapeutic areas.

• Strong comprehension of global drug development and regulatory processes, encompassing major regulatory milestones, health authority interactions, and submission requirements across key regions.

• Proven understanding of the complete product development and commercialization processes and the interdependencies that affect regulatory execution.

• Experience in developing and maintaining integrated plans within complex, matrixed organizations.

• Proven ability to coordinate and align activities across various indications, functions, regions, and stakeholders.

• Exceptional organizational skills with a demonstrated capacity to manage multiple priorities in a dynamic environment.

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where applicable.