Job Title: Principal Clinical Trial Regulatory Affairs (APAC Market)
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25001568
Updated: February 12, 2025
Job Summary:
The Principal Clinical Trial Regulatory Affairs (CTRA) role is responsible for overseeing the regulatory deliverables of assigned projects or programs, ensuring customer-focused leadership and technical execution. This role requires close collaboration with internal teams, clients, and functional leads to assess regulatory risks, gaps, and address operational aspects. The position also includes managing staff, maintaining strategic customer relationships, and supporting the regulatory activities across the life cycle of clinical trials.
Key Responsibilities:
Regulatory Expertise and Strategy Development:
Serve as the Regulatory Subject Matter Expert (SME) collaborating with functional area leads to address issues in the Site Activation pathway.
Participate in strategic development, including client meetings and portfolio discussions.
Oversee the regulatory submission process, including compiling and preparing regulatory submission packages, such as the EU Clinical Trial Regulation Part I dossier.
Review and assess regulatory compliance for core clinical trial documents (e.g., labeling).
Perform regulatory impact assessments for amendments or modifications during the project lifecycle and mitigate any identified risks.
Provide strategic input into submission plans and present progress at client meetings.
Team Leadership and Management:
Line management responsibilities, including employee selection, professional development, performance management, coaching, and mentoring.
Approve staff-related actions, such as time records, salary administration, corrective actions, and terminations.
Foster strong relationships with clients, offering tailored regulatory solutions and support in line with project objectives.
Ensure that project deliverables meet client and internal expectations, tracking progress, budgets, and risks.
Operational and Regulatory Tasks:
Coordinate and analyze regulatory submissions, including tracking submissions, handling Requests for Information (RFIs), and addressing regulatory concerns during submission review.
Manage the submission of country-specific applications, ensuring quality control and regulatory compliance.
Lead efforts to identify gaps in evidence supporting submissions and contribute to developing regulatory recommendations.
Support cross-functional teams in identifying regulatory issues and their impact on project delivery.
Manage project budgets, ensuring alignment with milestones and profitability targets.
Client and Stakeholder Management:
Build and maintain strategic relationships with clients, ensuring their needs are proactively assessed and met.
Act as the liaison between customers and internal teams to ensure successful regulatory outcomes.
Facilitate communication between customer leaders and senior management regarding regulatory issues.
Contribute to the development of new business opportunities and participate in proposal reviews.
Training and Knowledge Sharing:
Design and deliver training programs for departmental teams on regulatory processes and updates.
Provide guidance to entry-level employees, transferring knowledge and applying technical expertise.
Stay current with applicable regulations and industry standards, ensuring compliance with relevant laws.
Additional Responsibilities:
Ensure all documents are submitted to the Trial Master File (TMF) according to company SOPs and sponsor requirements.
Perform other tasks as required, with up to 25% travel potentially needed.
Qualifications:
Education: Bachelor’s Degree (Higher degree preferred).
Experience:
Expertise in regulatory frameworks for non-interventional studies, clinical trials, and medical devices.
Experience in GxP environments (e.g., GVP, GCP, ISO 14155).
Knowledge of clinical research management, drug development, and clinical project management procedures.
Experience with budgeting and quality management.
Proven ability to mentor and coach staff.
Skills:
Excellent communication and interpersonal skills (written and spoken).
Ability to influence, persuade, and lead teams effectively.
Strong problem-solving and negotiation skills.
Ability to coach employees to achieve performance objectives and provide constructive feedback.
Quality-driven approach to regulatory tasks and project management.
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Remote, USA | Remote - South America (Latin Americal) | Remote | Switzerland | Remote - Africa | Remote - Europe | Remote - Middle East |Bucharest :
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