Regulatory Affairs Scientist

Allucent

. Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance across development and lifecycle stages.

Posted 10/15/2026full-timeCary • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for drugs, biologics, and medical devices, with a strong focus on compliance, eCTD submissions, and regulatory strategy. Capable of mentoring junior team members and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Regulatory KnowledgeECTD SubmissionsRegulatory StrategyCross-Functional CollaborationMentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationChange Impact AssessmentPost-Approval Regulatory ActivitiesScientific Document ReviewRegulatory Compliance

Soft Skills

CollaborationCommunicationMentoring

Industry Keywords

Drug DevelopmentBiologic DevelopmentMedical Device DevelopmentUS Regulatory RequirementsEU Regulatory RequirementsCanada Regulatory Requirements

About the role

Key responsibilities & impact

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 while building regulatory expertise, staying current on evolving regulations, and mentoring junior team members.
Assist clients with regulatory affairs-related activities for drug, biologic, or medical device products.
Serve on project teams as a Subject Matter Expert, Assistant Consulting Lead, or Consulting Lead.

Requirements

What you’ll need

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

Benefits

Comp & perks

Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees