Operations Coordinator

Description:

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and guidance for clinical trials, ensuring timely, high-quality regulatory submissions in compliance with applicable regulations. The role includes:

• Providing regulatory guidance throughout the clinical development life cycle.

• Compiling, coordinating, and reviewing applications to Regulatory Authorities (CTA/IND, annual reports, amendments, scientific advice meetings, orphan designations, pediatric planning, marketing applications).

• Developing and reviewing documents for submission to Regulatory Authorities and Ethics Committees.

• Representing Global Regulatory Affairs in project team and business development meetings.

• Leading or coordinating regulatory affairs specialists to achieve submission targets.

• Maintaining project plans, trackers, and regulatory intelligence tools.

• Assisting in developing Regulatory Affairs Specialists and other operational staff.

• Staying updated on laws, regulations, and guidelines governing drug development.

• Providing ICH GCP guidance, advice, and training to internal and external clients.

Qualifications:

• Bachelor’s degree (scientific or healthcare discipline preferred).

• Regulatory experience: 5 years (Manager), 7 years (Senior Manager).

• Experience in Clinical Research Organizations, leading clinical submissions.

• Knowledge of drug development, regulatory milestones, and regulatory activities for at least one major region (EU, US).

• Familiarity with clinical and pre-clinical study results, clinical trial methodology, and pharmaceutical regulations.

• Fluent in English; computer literacy (MS Office/Office 365).

• Availability for domestic and international travel.

Competencies:

• Strong interpersonal and communication skills.

• Ability to manage multiple tasks and prioritize workload.

• Professionalism, self-motivation, flexibility, and team collaboration.

• Experience in process improvement, data collection, and delivering formal presentations.