Regulatory Affairs Scientist I

Allucent • Cary, NC

2d • Hybrid

About The Position

Allucent is seeking a Regulatory Affairs Scientist I to assist clients with regulatory affairs activities for drug, biologic, or medical device products. The role serves on project teams in capacities such as Subject Matter Expert, Assistant Consulting Lead, and Consulting Lead. The position is based near Cary, North Carolina, with office attendance expected 2–3 times per week. Allucent’s policy prescribes a minimum of two days in the office per week for employees within reasonable distance of a global office; remote or hybrid working may be available depending on location.

Requirements

• B.Sc., M.Sc., or equivalent degree in a scientific area, and an equivalent combination of relevant experience in drug, biologic, or device development.
• Regulatory knowledge of drug, biologic, or device development, focusing on regulatory requirements for the US, EU, and/or Canada.
• Based near Cary, NC, and able to come into the office 2–3 times per week.

Responsibilities

• Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance across development and lifecycle stages.
• Support regulatory strategy and Health Authority interactions, including briefing materials, meeting preparation, responses to inquiries, and reporting requirements.
• Translate regulatory guidance and submission requirements into practical plans, including eCTD submissions, change impact assessments, and post-approval regulatory activities.
• Collaborate with clients and cross-functional teams.
• Build regulatory expertise and stay current on evolving regulations.
• Mentor junior team members.
• Serve on project teams in capacities such as Subject Matter Expert, Assistant Consulting Lead, and Consulting Lead.

Benefits

• Comprehensive benefits package per location.
• Competitive salaries per location.
• Departmental study/training budget for professional development.
• Flexible working hours (within reason).
• Opportunity for remote/hybrid working depending on location.
• Leadership and mentoring opportunities.
• Participation in the Buddy Program as a new or existing employee.
• Internal growth opportunities and career progression.
• Internal employee referral program.
• Access to online soft-skills and technical training via internal platforms.
• Eligibility for the Spot Bonus Award Program.
• Eligibility for the Loyalty Award Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level