About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, vaccine, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, quality-as-a-service, medical affairs, toxicology, and technology solutions to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Role Summary:

The Associate Director of Regulatory Operations will lead our regulatory submissions and compliance activities. This leadership role is pivotal to ensuring efficient regulatory submission processes, maintaining high standards of quality, and overseeing global regulatory operations. The incumbent will work closely with internal teams, clients, and regulatory authorities to drive successful regulatory outcomes, ensuring compliance with FDA, EMA, and other global health authorities.

Key Responsibilities:

Leadership & Strategy

Provide strategic leadership and direction for the regulatory operations team, ensuring timely and compliant submissions.
Develop and implement regulatory operations strategies to enhance efficiency, quality, and compliance.
Work with team members to optimize project support while identifying opportunities for long term growth and development.
Collaborate with cross-functional teams (clinical, safety, quality assurance, medical writing) to drive regulatory strategy and operations.

Regulatory Submission Oversight

Act as a regulatory Subject Matter Expert for Regulatory Projects as needed.
Directly interact with clients about projects and opportunities.
Ensure compliance with global regulatory requirements and submission formats.
Oversee submission timelines, resource allocation, and project management to ensure milestones are met.

Quality & Compliance

Maintain high standards of regulatory document quality through rigorous review and approval processes.
Stay current with regulatory intelligence and industry best practices to ensure compliance with the latest global regulations and guidance.
Implement and manage systems for regulatory document tracking, submission tracking, and overall regulatory operations performance monitoring.

Team Management & Development

Lead, mentor, and manage a high-performing regulatory operations team, fostering a culture of continuous learning and professional development.
Provide coaching, guidance, and performance management to ensure team success.
Promote knowledge-sharing and best practices within the regulatory operations group and across the organization.

Client & Stakeholder Engagement

Serve as a regulatory operations expert in client meetings, providing strategic input on submission timelines, formats, and requirements.
Build strong relationships with clients and regulatory authorities, ensuring open lines of communication and responsiveness to feedback.
Work with business development teams to support new client opportunities and contribute to proposal development as needed.

Candidate Profile:

Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field. Advanced degree (e.g., MS, PhD, MBA) strongly preferred.
12+ years of experience in regulatory submissions and operations, preferably within the CRO, pharmaceutical, or biotech industry.
Proven track record of leading global regulatory submissions and managing teams in a fast-paced environment.
Deep knowledge of global regulatory requirements, submission formats (e.g., eCTD), and electronic submission systems.

Leadership Skills

Demonstrated success in managing and mentoring regulatory teams, driving results, and fostering collaboration.
Strong project management and organizational skills with a keen ability to prioritize tasks and manage multiple projects simultaneously.
Strong communication skills and the ability to interact directly with clients at all levels

Technical Skills

Proficiency with regulatory submission platforms (e.g., eCTD publishing software, electronic document management systems).
Advanced knowledge of Microsoft Office Suite and other document review and submission tools.

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Associate Director – Regulatory Operations

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