Job#: 3056987 Job Description: 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 is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
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