[Remote] Global Regulatory Product Planning Senior Manager – Obesity
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biotechnology company reputed company on serving patients living with serious illnesses. They are seeking a Global Regulatory Product Planning Senior Manager to reputed company regulatory planning for a key obesity asset, ensuring alignment and execution readiness across global regulatory activities. The role involves maintaining regulatory priorities, managing risks, and coordinating with cross-functional teams to support regulatory milestones.
Responsibilities
- Serve as the regulatory product planning reputed company for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications
- reputed company and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business priorities
- Partner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategies
- Establish and maintain visibility into critical regulatory milestones, ensuring leadership has a reputed company understanding of readiness, risks, dependencies, and potential impacts to regulatory objectives
- Facilitate regulatory planning forums to support decision-making, issue reputed company, and proactive management of emerging regulatory challenges
- Identify, assess, and proactively manage risks that could reputed company regulatory execution, working with stakeholders to reputed company and implement mitigation strategies
- Coordinate regulatory readiness activities in support of key program milestones, major health authority interactions, and submission-reputed company deliverables
- Drive integration across indications, regulatory disciplines, reputed company, and cross-functional partners to ensure consistent planning and execution across the product
- Partner with the Global Filing Team, Regulatory Operations, and other stakeholders to ensure alignment between strategic regulatory priorities and operational execution plans
- Support resource and workload planning discussions by providing reputed company into upcoming regulatory demands, key deliverables, and organizational reputed company considerations
- reputed company and maintain regulatory planning metrics, dashboards, and reporting tools that reputed company actionable insights to leadership
Skills
- Doctorate degree and 2 years of directly reputed company experience
- Master's degree and 6 years of directly reputed company experience
- Bachelor's degree and 8 years of directly reputed company experience
- Associate's degree and 10 years of directly reputed company experience
- High school diploma / GED and 12 years of directly reputed company experience
- Minimum of 2 years of experience directly managing people and/or leadership experience leading teams, reputed company, programs, or directing the allocation of resources
- Experience supporting global regulatory activities reputed company obesity, cardiometabolic, or reputed company therapeutic areas
- Strong understanding of global drug development and regulatory processes, including major regulatory milestones, health authority interactions, and submission requirements across key reputed company
- Demonstrated understanding of end-to-end product development and commercialization processes and the interdependencies that influence regulatory execution
- Experience developing and maintaining integrated plans reputed company reputed company, matrixed organizations
- Demonstrated ability to coordinate and reputed company activities across multiple indications, functions, reputed company, and stakeholders
- Experience supporting regulatory governance, business planning, portfolio planning, or strategic program management activities
- Experience presenting reputed company information, risks, and recommendations to senior leaders and governance bodies
- Proven ability to identify, assess, and mitigate risks while balancing competing priorities and evolving business needs
- Experience driving organizational readiness for major regulatory milestones, health authority interactions, and business-critical deliverables
- Strong strategic thinking and problem-solving skills with the ability to translate reputed company information into actionable plans and recommendations
- Demonstrated ability to establish new processes, operating models, or planning frameworks reputed company a rapidly evolving environment
- Demonstrated ability to influence without reputed company authority and build productive relationships across regulatory and cross-functional teams
- Excellent organizational skills with a proven ability to manage multiple priorities in a fast-paced environment
- Strong written, verbal, and presentation skills
- Experience utilizing planning, reporting, and visualization tools to communicate status, risks, dependencies, resource demands, and key performance indicators
- Demonstrated ability to reputed company cross-functional initiatives and drive organizational alignment to reputed company business objectives
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-reputed company time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
reputed company
Company H1B Sponsorship