Director of Regulatory and Submission

OPIS

Remote, Europe

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 full home based role in one of the European countries where OPIS has it's affiliate.

What You’ll Do:

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.

Who You Are:

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.

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