Remote Global Regulatory Lead - Cardiovascular NDA

Medasource; United States; Remote; USD 165,000 - 193,000; Part time

Job summary

Medasource is seeking a Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) to provide strategic regulatory leadership for a late-stage cardiovascular program. The role oversees NDA activities, global submissions, and Health Authority interactions across development stages.

The successful candidate will helm global regulatory strategies, manage cross-functional teams, and navigate complex regulatory environments to support timely product registration.

Qualifications

• Bachelor’s, Master’s, PhD, MD, or PharmD in a relevant scientific discipline.
• 4–7+ years of experience in pharmaceutical Regulatory Affairs with significant involvement in regulatory strategy and drug development.
• Prior experience serving as a Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL).
• Experience developing and executing regulatory strategies for pharmaceutical development programs.
• Strong understanding of global and U.S. regulatory requirements, submission processes, and Health Authority interactions.
• Excellent communication, organizational, and cross-functional leadership skills.

Responsibilities

• Serve as the Global Regulatory Lead (GRL) and/or U.S. Regulatory Lead (USRL) for a late-stage cardiovascular development program.
• Develop and execute global regulatory strategies aligned with clinical development plans, program objectives, and business goals.
• Provide regulatory leadership throughout key development milestones, including Database Lock (DBL), NDA preparation, submission, and regulatory review.
• Lead internal and joint Global Regulatory Teams (GRTs), ensuring effective collaboration, decision-making, and execution across partner organizations.
• Identify potential regulatory risks and develop alternative strategies to support successful product registration.
• Lead regulatory planning and readiness activities for an original NDA submission currently underway.
• Oversee global submission activities, ensuring cross-functional alignment, integrated planning, and timely execution.
• Develop product registration strategies and translate regulatory requirements into actionable operational plans.
• Provide strategic oversight of U.S. regulatory submissions, ensuring compliance with applicable regulatory requirements.
• Identify, communicate, and elevate regulatory risks while developing appropriate mitigation strategies.
• Develop and execute global and U.S. Health Authority engagement strategies.
• Lead regulatory interactions with Health Authorities in collaboration with regional and local regulatory teams.
• Provide strategic guidance on regulatory agency communications, submission approaches, and potential regulatory challenges.
• Support the preparation of briefing documents, regulatory meeting materials, and responses to Health Authority inquiries.
• Lead discussions and negotiations with regulatory agencies to support program objectives.
• Partner with clinical development, regulatory affairs, and other cross-functional teams to ensure regulatory considerations are incorporated into development plans.
• Collaborate with internal stakeholders and external regulatory partners to align strategies, timelines, and regulatory deliverables.
• Lead discussions and facilitate resolution of complex regulatory issues involving multiple technical and functional teams.
• Communicate regulatory strategies, risks, and recommendations to senior leadership and key stakeholders.
• Provide regulatory input and strategic guidance for clinical study protocols, clinical study reports, nonclinical reports, statistical analysis plans, and regulatory submission documents.
• Contribute to the development of Target Product Profiles (TPPs), Company Core Data Sheets (CCDS), and global labeling strategies.
• Support U.S. and country-specific labeling requirements to ensure alignment with regulatory expectations.
• Ensure regulatory documentation and submission strategies support successful product development and registration.

Skills

Regulatory Affairs

GRL/USRL experience

Regulatory strategy

Regulatory submissions

Communication

Education

Bachelor's, Master's, PhD, MD, or PharmD in a relevant field

Job description

Medasource is seeking a Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) to provide strategic regulatory leadership for a late-stage cardiovascular program. The role oversees NDA activities, global submissions, and Health Authority interactions across development stages.

The successful candidate will helm global regulatory strategies, manage cross-functional teams, and navigate complex regulatory environments to support timely product registration.