Manager, Cross-Regional Operations – Strategic Support, Regulatory Affairs

Johnson & Johnson

. Implement regional regulatory strategies and regulatory submission plans aligned with R&D, regional, and local business objectives .

Posted 11/9/2026full-timeUnited StatesMid-LevelSenior💰 $120,000 - $207,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in pharmaceutical regulatory affairs, including the development and execution of regional regulatory strategies and submission plans. Proficient in managing cross-functional teams and ensuring compliance with global drug development regulations.

Highest-signal resume keywords

Pharmaceutical Regulatory ExperienceProject Management SkillsGlobal Regulatory Affairs ExpertiseExcellent Communication SkillsKnowledge of Drug Development Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PlanningPreparation of Registration DossiersDevelopment of Labeling StrategiesManagement of Local Submission RequirementsExperience with iCTD and ACTDRegulatory Input for InspectionsTactical ImplementationProject Team LeadershipRegulatory Strategy DevelopmentKnowledge Management Skills

Soft Skills

Ability to Work in a Multicultural EnvironmentAbility to Handle Multiple ProjectsExcellent Verbal and Written Communication SkillsAbility to Thrive in a Matrix EnvironmentFlexibility for Different Time Zones

Tools & Technologies

Gen AI ToolsCopilot

Industry Keywords

Global Drug DevelopmentHealth Authority MeetingsRegulatory CompliancePharmaceutical IndustryAP, LA, and EMEA Experience

About the role

Key responsibilities & impact

Implement regional regulatory strategies and regulatory submission plans aligned with R&D, regional, and local business objectives
Represent regions and contribute to regional and global regulatory strategy through product-related teams
Provide team leadership for Global Regulatory Teams, submission teams, Labeling Working Groups, CTA Working Groups, response teams, and clinical teams as appropriate
Advise product teams on regional and local requirements and supply-chain impacts on regional registrations
Lead Regional Working Groups and align regional deliverables with global team deliverables
Facilitate tactical implementation at the regional level and maintain effective communication with regional and global teams
Leverage strategic, tactical, operational, and procedural synergies across regions
Provide regulatory input and follow-up for inspections, audits, litigation support, and product complaints
Liaise with Local Operating Companies and support preparation for regional health-authority meetings
Oversee timely management of responses to Health Authority questions in line with product strategy
Develop regional marketing approval submission plans, tactical plans, timelines, and submission documents throughout product lifecycles
Prepare registration dossiers, including iCTD and ACTD, and dossier reuse strategies
Manage and track country-specific local submission requirements, including legal and technical documents and RMPs
Oversee development of regional labeling negotiation strategies and supporting documentation
Use Gen AI tools such as Copilot

Requirements

What you’ll need

Bachelor's degree with 8 years relevant experience, including 5 years pharmaceutical regulatory experience; or Master's/PharmD with 6 years relevant experience, including 4 years pharmaceutical regulatory experience; or PhD with 4 years relevant experience, including 3 years pharmaceutical regulatory experience
Breadth of global regulatory affairs experience in global drug development and commercialized products
Pharmaceutical regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience
Ability to independently handle multiple projects
Excellent verbal and written communication skills
Ability to work and thrive in a multicultural environment
Ability to work in a matrix environment
Ability to work flexible hours for early morning/late evening meetings with different time zones
Excellent English verbal and written communication skills
Experience working on or leading project teams
Demonstrated project management skills
Experience specifically in AP, LA, and EMEA countries desirable
Working knowledge of regulations and guidelines related to drug development and registration desirable
Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development desirable
Knowledge management skills and experience desirable
Demonstrated contribution to drug development projects and implementation of strategies desirable
Candidates must already have authorization to work in the country of employment
Immigration sponsorship and relocation support are not available
Candidates authorized to work pursuant to short-term status who require future immigration sponsorship are not eligible

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Eligible for severance
Hybrid work arrangement
Occasional travel of less than 10%