Senior Regulatory Affairs Associate- Clinical Trial Application

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Clinical Trial Submission Lead to join our team in a remote capacity. As a Clinical Trial Submission Lead, you will drive end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World regions. This position plays a critical role in ensuring timely, high-quality, and compliant submissions that advance new treatments for patients. You will leverage regulatory expertise, cross-functional collaboration, and proactive risk management to navigate complex global regulatory environments and deliver exceptional results.

You will collaborate with global teams, manage clinical and regulatory documentation, and contribute to study operations from planning through submission closeout. This role offers opportunities to deepen your expertise in regulatory submissions, expand your influence across international markets, and shape the future of clinical trial delivery.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership and operational excellence. With diverse teams and continuous learning opportunities, the Clinical Trial Submission Lead can explore career paths and expand skills across clinical research and regulatory affairs.

Key Responsibilities

· Lead end-to-end Clinical Trial Application project management across multiple studies and countries, ensuring alignment with timelines and regulatory requirements

· Plan, track, and deliver submissions across EU CTR and Rest of the World regions with meticulous attention to compliance and quality standards

· Manage risks, dependencies, and complexities in global regulatory environments through proactive identification and mitigation strategies

· Apply deep knowledge of EU CTR and ROW CTA requirements to ensure submissions meet all regulatory expectations

· Manage core clinical and regulatory documentation, maintaining accuracy and completeness throughout the submission lifecycle

· Collaborate with cross-functional global teams including clinical, regulatory, and operations to coordinate seamless submission execution

· Build and maintain strong stakeholder relationships across internal and external partners, resolving conflicts and ensuring alignment

· Monitor key performance indicators related to submission timelines and deliverable quality, driving continuous improvement

· Identify emerging risks and lead quality investigations as needed to maintain submission integrity

You will thrive in this role if you bring:

· Strengths in project management, regulatory knowledge, and stakeholder engagement

· Experience working in clinical research, pharmaceutical, or CRO environments

· The ability to collaborate across global teams and communicate clearly with diverse audiences

· A patient-focused mindset and strong attention to detail in regulatory submissions

· Comfort working with clinical trial management systems and regulatory documentation platforms

Required Qualifications

· Bachelor's degree in Life Sciences, Pharmacy, or related field

· Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar regulated environments

· Demonstrated experience in Clinical Trial Application submissions (EU CTR and Rest of the World)

· Strong project management experience in global and matrix environments

· Knowledge of clinical trial processes and regulatory requirements

· Strong communication, organization, and problem-solving skills

Preferred Qualifications

· Advanced degree or professional certification in regulatory affairs or clinical research

· Experience with regulatory submission systems and electronic trial master files (eTMF)

· Familiarity with ICH-GCP guidelines and international regulatory pathways

· Experience managing submissions across multiple therapeutic areas or study phases