Director of Regulatory and Start-up

Opis; Town of Italy (NY); Remote; USD 120,000 - 160,000; Full time

Job summary

A leading international clinical research organization is seeking a Director of Regulatory and Submissions to lead global regulatory operations and ensure compliance across projects. The ideal candidate will have at least 10 years of experience in regulatory roles within CROs and a scientific degree in pharmaceutical sciences. This role offers competitive compensation, professional growth, and an opportunity to guide a high-performing team in a dynamic environment.

Benefits

Competitive salary

Benefits package

Professional growth opportunities

Qualifications

• Minimum 10 years in regulatory roles within CRO settings.
• Proven experience leading a global team.
• In-depth understanding of ICH, GCPs, FDA standards.

Responsibilities

• Lead global regulatory operations across all projects.
• Develop regulatory strategies and oversee submissions.
• Serve as a liaison for regulatory agency interactions.

Skills

Leadership

Regulatory knowledge (FDA, ICH, GCP)

Communication

Strategic thinking

Project management

Education

Scientific degree in pharmaceutical sciences

Job description

Overview

We are seeking a Director of Regulatory and Submissions to take charge of our regulatory leadership and ensure our client projects meet the highest quality standards. This pivotal role offers a unique opportunity to lead a high-performing team, work closely with regulatory authorities across EU, FDA and Asia Pacific, and shape the regulatory strategy and submissions within a dynamic, fast-growing Clinical Research Organization.

This is a fully home based role in one of the European countries where OPIS has its affiliate.

Responsibilities

• Lead global regulatory operations to achieve excellence in compliance and quality across all global projects, staying ahead with up-to-date knowledge on FDA, GCP, and ICH guidelines for clinical investigations.
• Lead your team to develop robust regulatory strategies, oversee submissions to Competent Authorities and Ethics Committees, and manage Clinical Trial Applications to meet strict project timelines and achieve timely approvals.
• Provide guidance and support for the development of the Grant Plan and for the negotiation of contracts with Sites;
• Serve as the liaison for all regulatory agency interactions, facilitating smooth, transparent communication across stakeholders to maintain alignment and address any potential challenges early.
• Build a culture of growth, mentorship, and high performance within the regulatory team. Conduct skill-development activities, annual reviews, and foster career advancement for your team.
• Partner with Business Development on proposals and bid defenses, offering expert insights and supporting the proposal team with regulatory requirements and cost projections to drive new business opportunities.
• Ensure that the regulatory team’s performance metrics are met, including budget adherence and efficient resource allocation, to contribute to our company’s financial objectives.

Qualifications

• You hold a scientific degree, bringing with you an extensive foundation in pharmaceutical sciences.
• Minimum 10 years in regulatory roles within CRO settings, with proven experience leading a global team.
• In-depth understanding of ICH, GCPs, FDA, and other regulatory body standards, as well as regulatory requirements for a wide array of clinical studies (Phase I-IV, PASS, PAES).
• Proactive and solutions-oriented, with the ability to inspire a high-performing team and lead multiple complex projects.
• A strategic thinker who excels in customer service and cross-departmental collaboration, with strong verbal and written communication skills.

What we offer

We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth, innovation, and customer success.

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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