Manager, Global Development Process & Procedures Operations

Regeneron

Process & Procedure Operations Manager at Regeneron facilitating process development in the pharmaceutical industry. Collaborating with stakeholders and ensuring compliance with regulatory requirements and training.

Posted 7/28/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $114,800 - $187,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Procedural Writing and Process Development within the pharmaceutical industry, with a strong focus on Regulatory Affairs and Pharmacovigilance. Capable of managing cross-functional teams and ensuring compliance with regulatory requirements while maintaining effective communication and organizational skills.

Highest-signal resume keywords

Procedural Writing ExperienceProcess DesignRegulatory Affairs KnowledgePharmacovigilance ExperienceAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Procedural Document PrinciplesProcess MappingProcess ImprovementContent ManagementCross-Functional Coordination

Soft Skills

Effective CommunicationAttention to DetailOrganizational SkillsEmotional IntelligenceAbility to Work Independently

Tools & Technologies

Learning Management System

Industry Keywords

Pharmaceutical IndustryClinical DevelopmentQualityProduct ComplaintsMedical Affairs

About the role

Key responsibilities & impact

Leads/facilitates Process and Procedural Development projects with the respective document owner/Subject Matter Experts, to support development/improvement of the related process (New and Revised)
Coordinates the development, review, content/comment management and approval of the Procedural Document with the document owner/SME including the writing of the procedural and associated documents, as applicable
Initiates and manages cross-functional review cycles ensuring the appropriate SME reviewers
Verifies procedural documents do not conflict with other procedures or with regulatory requirements
Liaises with the Training function and the document owner to ensure that training requirements are implemented and current within the REGN Learning Management System

Requirements

What you’ll need

Strong Procedural writing experience within the pharmaceutical industry
Ability to translate operational needs into a process map and procedural document
Proven ability to work effectively across multiple stakeholders
Effective communicator (written and oral)
Ability to work independently
Proven track record to manage multiple responsibilities and priorities
Experience in working in or with Pharmacovigilance and knowledge of Regulatory Affairs, Medical Affairs, Clinical Development, Quality, and/or Product Complaints
Analytical skills with ability to navigate through scenarios
Experience in procedural document principles, process design, and process improvements is required
Attention to detail with demonstrated organizational and emotional intelligence/awareness
Knowledge of Pharmacovigilance regulatory requirements
Bachelors Degree and 7+ years of relevant experience

Benefits

Comp & perks

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits