Biotech & Pharma OPT Jobs in North Carolina

INTRODUCTION

The Regulatory Science & Strategy (RSS) team is a specialized regulatory consulting group that supports pharmaceutical, biotechnology, and medical device companies across the product lifecycle. The RSS team helps clients navigate complex regulatory challenges, develop evidence-generation strategies, engage health authorities, and evaluate innovative approaches including real-world evidence (RWE), regulatory intelligence, AI-enabled regulatory technologies, and novel development pathways.

The Associate Consultant plays a key supporting role in the delivery of strategic regulatory engagements. Working alongside senior RSS team members, epidemiologists, and former regulators, this individual contributes to regulatory research, landscape assessments, evidence-generation planning, client deliverables, and business development support activities.

ESSENTIAL FUNCTIONS

Project Delivery:

• Support the execution of regulatory science and strategy consulting engagements across drugs, biologics, medical devices, diagnostics, and combination products.
• Perform literature reviews, regulatory precedent analyses, and landscape assessments across global regulatory agencies.
• Conduct reviews of regulatory guidance, policies, public health authority communications, and scientific publications to support client objectives.
• Assist in the development of evidence-generation strategies involving RWE.
• Support assessments of real-world data sources, patient registries, natural history studies, and external control strategies.
• Contribute to regulatory intelligence deliverables that summarize evolving regulatory expectations, precedents, and emerging trends.

Analysis & Insights:

• Synthesize scientific, clinical, and regulatory information into concise, decision-oriented insights.
• Support benchmarking activities across products, therapeutic areas, and regulatory jurisdictions.
• Assist with policy monitoring and horizon scanning activities.
• Analyze publicly available regulatory documents, advisory committee materials, approval packages, and guidance documents.

Client Deliverables:

• Develop high-quality PowerPoint presentations, reports, briefing materials, and strategic recommendations.
• Support meeting preparation, note taking, action-item management, and project coordination activities.
• Contribute to client-facing discussions and internal working sessions.
• Ensure deliverables meet quality, scientific, and regulatory standards.

Business & Practice Support:

• Support proposal development, opportunity assessments, and thought leadership initiatives.
• Assist with preparation of conference presentations, publications, white papers, and marketing content.
• Contribute to internal knowledge management activities and methodology development.
• Participate in practice-wide initiatives focused on regulatory innovation, regulatory intelligence, and AI-enabled solutions.

QUALIFICATIONS

Required:

• Master’s degree or equivalent advanced degree in Regulatory Affairs or Regulatory Science, Epidemiology, Public Health, Health Outcomes Research, Pharmacy, Biomedical Sciences, Life Sciences, or a related discipline; OR
• Bachelor’s degree with demonstrated experience in regulatory affairs, consulting, evidence generation, life sciences research, or related fields.

Preferred:

• Experience interpreting regulatory authority guidance.
• Knowledge of clinical development, regulatory pathways, and evidence-generation principles.
• Exposure to regulatory intelligence, real-world evidence, epidemiology, or medical writing.
• Familiarity with emerging topics such as artificial intelligence in healthcare, rare disease development, digital twins, and external controls.

Knowledge, Skills, and Abilities:

• Strong analytical and problem-solving skills.
• Ability to synthesize complex scientific and regulatory information.
• Excellent written and verbal communication skills.
• Strong attention to detail and commitment to quality.
• Ability to work effectively within cross-functional teams.
• Ability to manage multiple priorities and deadlines simultaneously.
• Proficiency in Microsoft PowerPoint, Word, and Excel.
• Curiosity and willingness to learn in fast-paced, evolving scientific and regulatory environments.
• Comfort working in ambiguity and supporting innovative client challenges.

CAREER PROGRESSION EXPECTATIONS

At the Associate Consultant level, individuals are expected to:

• Build foundational expertise in regulatory science and strategy.
• Independently execute defined workstreams with limited oversight.
• Develop client-facing consulting skills.
• Contribute to thought leadership and knowledge development activities.
• Progress toward ownership of increasingly complex project tasks and client interactions.

This role serves as a foundational consulting position within RSS and provides exposure to innovative regulatory challenges across the product lifecycle, including regulatory strategy, regulatory intelligence, regulator interactions, real-world evidence, and emerging regulatory technologies.

COMPENSATION

• The potential base pay range for this role, when annualized, is $58,700.00 - $146,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

LOCATION

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

CULTURE

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.