Regulatory Affairs Scientist I

Allucent; Cary (NC); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Flexible hours

Remote/hybrid options

Mentoring program

Training budget

Career progression

Job summary

Allucent is seeking a Regulatory Affairs Scientist I to support regulatory activities for drugs, biologics, or devices and contribute to project teams in various roles.

The candidate will prepare regulatory documents, assist with HA interactions, and translate guidance into actionable plans while collaborating with cross-functional teams and mentoring junior colleagues. The role is based near Cary, NC with 2–3 days in the office and potential remote/hybrid arrangements.

Qualifications

• BSc/ MSc in a scientific field or equivalent experience.
• Regulatory knowledge spanning US, EU, and/or Canada.
• Willingness to work in a hybrid office setting near Cary, NC.

Responsibilities

• Prepare and review regulatory documents for drugs, biologics, or devices across development and lifecycle stages.
• Support regulatory strategy and Health Authority interactions, including briefing materials and responses to inquiries.
• Translate regulatory guidance into practical plans, including eCTD submissions and post-approval activities.
• Collaborate with clients and cross-functional teams while mentoring junior team members.

Skills

Regulatory affairs

Cross-functional teamwork

Regulatory strategy

Document review

Education

B.Sc. in Life Sciences

M.Sc. in Regulatory Science

Job description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

About the Role

Bring your expertise in regulatory affairs and join Allucent as a Regulatory Affairs Scientist I to assist clients with regulatory affairs related activities for drug, biologic, or medical device products and serve on project teams in various capacities such as Subject matter Expert, Assistant Consulting Lead, and Consulting Lead.

Your main responsibilities will include but not limited to:

• 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 (HA) 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.

About you

• 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

About Allucent

Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

Benefits of working at Allucent include:

• 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

Disclaimers:

*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.