Global Regulatory Lead

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

Global Regulatory Lead (GRL) / US Regulatory Lead (USRL)

Location: Remote – Open to all U.S. time zones

Employment Type: 6-Month Contract-to-Hire

Compensation: $120–$140/hour

Schedule: Full-Time | 40 hours per week

Start Date: ASAP

About the Role

We are seeking an experienced Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) to provide strategic regulatory leadership for a late-stage cardiovascular drug development program.

This individual will play a critical role in developing and executing global and U.S. regulatory strategies, overseeing New Drug Application (NDA) submission activities, and supporting key regulatory milestones throughout the development and registration process.

The ideal candidate will have a strong background in pharmaceutical regulatory affairs, previous experience supporting cardiovascular drug development programs, and demonstrated success leading global regulatory strategies and submissions. This position requires an individual who can effectively navigate complex regulatory environments, collaborate across cross-functional teams, and provide strategic guidance throughout the product development lifecycle.

Key Responsibilities

Global Regulatory Strategy & Leadership

• 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.

NDA Submission & Regulatory Oversight

• 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.

Health Authority Engagement

• 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.

Cross-Functional Collaboration

• 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.

Regulatory Documentation & Strategic Support

• 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.

Required 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.

Preferred Qualifications

• Experience leading regulatory strategy and submission activities for late-stage pharmaceutical development programs, including NDA submissions.
• Proven success developing and implementing global regulatory strategies supporting clinical development and product registration.
• Experience leading complex, cross-functional teams across multiple geographies and partner organizations.
• Strong ability to communicate regulatory strategies, risks, and recommendations to senior leadership.
• Demonstrated success negotiating regulatory objectives with Health Authorities.
• Ability to translate complex scientific and regulatory information into actionable business recommendations.
• Experience working within strategic partnerships involving multiple pharmaceutical organizations.