Principal Clinical Trial Regulatory Affairs

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Acts as a Regulatory Subject Matter Expert, collaborating with key functional area leaders to identify and assess essential issues related to the Site Activation pathway.

• Engages in strategic development activities, including client account and portfolio meetings.

• May oversee and participate in departmental staff operations, which include interviewing and selection, preparing job descriptions, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.

• Authorizes decisions concerning salary administration, hiring, corrective actions, and terminations.

• Reviews and approves time records, expense reports, leave requests, and overtime submissions.

• Advises staff on administrative policies and procedures, technical challenges, priorities, and operational methods.

• Cultivates and maintains strategic relationships with clients in alignment with their assigned projects, including processes and solutions, while proactively assessing client needs.

• Ensures that all project deliverables align with both internal and client expectations as outlined in contractual agreements, providing accurate projections, reports, updates, and continuous risk assessments.

• Collaborates with project leadership to outline strategies for achieving milestones and key deliverables. Prepares and presents the overall Regulatory strategy and status during client meetings and communicates outcomes to the project team.

• Takes responsibility for CTRA operations concerning specific project activities, which may include but are not limited to...

• Updates plans in accordance with Standard Operating Procedures and/or sponsor-defined processes. Gathers all controlled document requirements and other necessary elements to ensure high-quality deliverables.

• Prepares, assists with, and presents the overall submission strategy and status at client meetings, communicating outcomes to the project team.

• Reviews core documents for clinical trial studies (such as regulatory compliance labeling, etc.).

• Coordinates and/or executes regulatory core submissions (for instance, the EU Clinical Trial Regulation Part I dossier) and monitors submission packages at the study level.

• Centralizes and conducts a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as Requests for Information RFIs during the submission review).

⛳️ Requirements

• Over 4 years of experience in regulatory submissions within LATAM.

• Bachelor’s Degree; a Higher Degree is preferred.

• Expertise in current regulatory frameworks (e.g., regulations and guidelines specific to non-interventional studies, clinical trials, and medical devices).

• Experience working in accordance with applicable GxPs (e.g., GVP, GCP, ISO 14155, etc.).

• Strong understanding of clinical research management processes.

• Comprehensive knowledge of relevant regulations, drug development, and clinical project management procedures.

• Prior experience in budgeting and quality management.

• Ability to teach and mentor team members.

• Capability to coach employees to achieve performance objectives.

• Proficiency in recognizing and addressing situations when employee performance is below expectations.

• Excellent communication and interpersonal skills (both written and verbal) with the ability to influence, persuade, and work effectively within a team.

• Quality-focused in all managed activities.

• Strong negotiation and problem-solving abilities.

• Demonstrated capability to provide constructive feedback and guidance to colleagues.

🏝️ Benefits

• We are dedicated to the growth of our employees through career development and advancement opportunities; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.