Global Regulatory Lead

Apex Systems; Overland Park (KS); Remote; USD 160,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401K

ESPP

HSA

Career coaching

Training programs

Discounts

Education resources

Job summary

Everforth Apex Systems is recruiting a Global Regulatory Lead to provide strategic regulatory leadership for a late‑stage cardiovascular development program, driving global strategies and NDA activities across multiple regions.

The role requires leading cross‑functional teams, coordinating regulatory submissions, and engaging with health authorities to ensure timely product registration and risk mitigation across partner organizations.

Qualifications

• PhD/MD/PharmD/MS/BS in a relevant scientific discipline.
• 4+ years in Regulatory Affairs with cardiovascular drug development.
• Global regulatory experience across EU, JP, AU and other regions.

Responsibilities

• Lead global regulatory strategies for a late-stage cardiovascular program.
• Coordinate NDA preparation, submission, and review activities.
• Drive regulatory readiness and risk mitigation across teams.
• Engage health authorities and lead agency interactions globally.
• Collaborate with clinical, nonclinical, and biostatistics teams.
• Provide SME input on protocols, reports, and labeling strategies.

Skills

Global Regulatory Lead

Regulatory strategy

NDA submissions

Cross-functional leadership

Multi-region regulatory

Education

PhD/MD/PharmD/MS/BS in relevant field

Job description

Job#: 3056987

Global Regulatory Lead

Location: Remote

Role Overview

The Regulatory Specialist provides strategic regulatory leadership for a late-stage cardiovascular development program, serving as the primary regulatory lead for a key investigational asset. This role drives global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities. The successful candidate will leverage a strong background in cardiovascular drug development to lead complex matrix teams and navigate key regulatory pathways.

Key Responsibilities

• Serve as the regulatory lead for a late-stage cardiovascular development program, establishing and executing global regulatory strategies.
• Provide strategic leadership throughout key development milestones, including Database Lock, NDA preparation, and submission activities.
• Lead and facilitate internal and joint regulatory teams, driving collaboration, decision-making, and execution across partner organizations.
• Drive regulatory readiness and execution for original NDA submissions, ensuring cross-functional alignment and risk mitigation.
• Develop product registration strategies and translate them into actionable operational plans.
• Develop and execute asset-specific health authority engagement strategies, leading interactions with global regulatory agencies.
• Serve as a regulatory subject matter expert, providing strategic guidance on agency communications and submission approaches.
• Collaborate with clinical, nonclinical, biostatistics, and development teams to ensure regulatory considerations are incorporated into program plans.
• Provide strategic regulatory input to Clinical Study Protocols, Clinical Study Reports, and nonclinical summaries.
• Contribute to the development of Target Product Profiles, Company Core Data Sheets, and global labeling strategies.

Required Qualifications

• Education: A PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.
• Experience: Significant experience in Regulatory Affairs, typically 4 or more years, with a proven track record supporting cardiovascular drug development programs.
• Technical Skills: Prior experience serving as a Global Regulatory Lead, with demonstrated experience leading major regulatory submissions and health authority interactions. Global regulatory experience spanning multiple regions, such as the European Union, Japan, Australia, and other countries.

Preferred Qualifications

• Proven success developing and implementing global regulatory strategies that support clinical development and product registration.
• Strong experience communicating regulatory strategy, risks, and recommendations to senior leadership and cross-functional stakeholders.
• Demonstrated ability to lead complex matrix teams across multiple functions and geographies.
• Proven success negotiating regulatory objectives with global health authorities.

Everforth Apex Benefits Overview

• medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection.
• ESPP (employee stock purchase program)
• 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure.
• HSA (Health Savings Account on the HDHP plan)
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
• corporate discount savings program and other discounts
• on-demand training program
• certification prep
• library of technical and leadership courses/books/seminars once you have 6+ months of tenure
• certification discounts and other perks to associations that include CompTIA and IIBA
• dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach
• full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Benefits Department at [email protected] or 804-523-8228. (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex.

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Everforth Apex Systems is part of the Commercial Segment of Everforth, Inc.

NYSE: EFOR

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