Regulatory Affairs Scientist
About The Position
Allucent is dedicated to helping small- and medium-sized biopharmaceutical companies navigate clinical trials and bring therapies to patients. The Regulatory Affairs Scientist I or II assists clients with regulatory affairs activities for drug, biologic, or medical device products and contributes to project teams in roles such as Subject Matter Expert, Assistant Consulting Lead, and Consulting Lead. The position involves preparing and reviewing regulatory and scientific documents, supporting regulatory strategy and Health Authority interactions, and translating regulatory guidance and submission requirements into practical plans. The role also collaborates with clients and cross-functional teams, develops regulatory expertise, keeps current with evolving regulations, and mentors junior team members. The role is based near Cary, North Carolina, and requires coming to the office two to three times per week.
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, with a focus on regulatory requirements for the US, EU, and/or Canada.
- Be based near Cary, NC, and able to come into the office two to three times per week.
Responsibilities
- Prepare and review regulatory and scientific documents for drug, biologic, or device products, 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 or 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.
- Financially rewarding 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
