Regulatory Project Manager — Pharmaceutical (Remote/Onsite — Indianapolis, IN) Contract

BADRI Management Consultancy; Indianapolis (IN); Remote; USD 80,000 - 120,000; Full time

Job summary

An exciting opportunity awaits a detail-oriented Regulatory Project Manager in the pharmaceutical industry. This role involves supporting a Clinical Trial Patient Engagement Team by monitoring the evolving regulatory landscape and ensuring compliance with current regulations. The ideal candidate will conduct impact analyses and develop proactive strategies to navigate the complexities of drug development. Join a forward-thinking consultancy that values expertise and innovation, and make a significant impact on patient health and safety through your work. If you're ready to take on this challenge and contribute to meaningful projects, this position is perfect for you.

Qualifications

• 3+ years of experience in regulatory project management or clinical trials.
• In-depth knowledge of clinical trial regulations and drug development.

Responsibilities

• Monitor and analyze changes in the clinical trial regulatory environment.
• Develop strategies to ensure compliance with evolving regulations.

Skills

Regulatory Project Management

Clinical Trials

Market Research

Policy Analysis

Strategic Thinking

Problem Solving

Communication Skills

Education

Bachelor's Degree in Life Sciences or related field

Job description

Regulatory Project Manager — Pharmaceutical (Remote/Onsite — Indianapolis, IN) Contract

• Industry Pharma/Biotech/Clinical Research
• Remote Job

About Us

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

This is a remote position.

Our Fortune 500 Pharmaceutical client has an exciting opportunity for Regulatory Project Managers.

Job Summary:

We are seeking a detail-oriented and strategic Regulatory Project Manager to support a project with one of our clients in their Clinical Trial Patient Engagement Team. 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.

Key Responsibilities:

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

Qualifications:

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

Other Details:

Schedule: Full time, 40 hours per week

Contract Length: 18 months with renewal

Work Setup: Indianapolis preferred, but will consider Remote for very strong candidates

Resources Needed: 2

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.