Job Description

Regulatory Affairs, Project Manager - Contract - Remote, Indianapolis

Proclinical is looking for a detail-oriented and strategic Regulatory Project Manager to support a project with one of our clients in their Clinical Trial Patient Engagement Team.

Primary Responsibilities:

This role is critical in monitoring the evolving clinical trial regulatory landscape and ensuring compliance with current regulations. The ideal candidate will conduct impact analyses, develop proactive response strategies, and stay updated on the latest drug development trends, policies, and regulatory changes to guide project decision-making. This is an opportunity to work with one of our clients in their Clinical Trial Patient Engagement Team, supporting innovative approaches to patient-centered clinical research.

Skills & Requirements:

• Minimum of 3+ years of experience in regulatory project management, clinical trials, or drug development.
• In-depth knowledge of regulatory environments related to clinical trials and drug development.
• Proven experience in market research, policy analysis, and regulatory impact assessment.
• Exceptional attention to detail and the ability to manage multiple projects and priorities simultaneously.
• Excellent communication and interpersonal skills for interacting with cross-functional teams and stakeholders.

The Regulatory Affairs, Project Manager's responsibilities will be:

• Regulatory Landscape Monitoring: Continuously track and analyse changes in the clinical trial regulatory environment and evaluate their potential impact on ongoing and future projects.
• Response Strategy Development: Develop and implement strategies to ensure compliance with evolving regulations and industry standards.
• Research & Market Analysis: Conduct in-depth research on public websites, regulatory updates, and drug development trends to stay informed of industry shifts.
• Impact Assessment: Use market research to assess the effect of new policies and regulations on current and upcoming clinical trial projects.
• Strategic Thinking & Problem Solving: Apply critical thinking to anticipate regulatory challenges and proactively propose solutions to ensure smooth project progression.
• Regulatory Knowledge: Maintain a thorough understanding of clinical trial regulations, processes, and policies, providing insight and guidance to support decision-making across teams.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at B.Forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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