Regulatory Affairs Scientist I — Hybrid/Remote Growth

Xtalks; Cary (NC); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Flexible hours

Remote/hybrid depending on location

Training budget

Job summary

Allucent is seeking a Regulatory Affairs Scientist I to support regulatory activities for drug, biologic, or device programs and contribute to project teams across roles such as Subject matter Expert and Consulting Lead.

You will prepare regulatory documents, assist with HA interactions, and translate guidance into practical plans, including eCTD submissions, while mentoring junior members and staying current with evolving regulations. Hybrid work options available.

Qualifications

• Regulatory knowledge for US FDA, Health Canada, or European authorities.
• B.Sc., M.Sc., or equivalent degree in a scientific field.
• 1+ years of Regulatory experience or similar exposure.

Responsibilities

• Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance.
• Support regulatory strategy and Health Authority interactions, including briefing materials and meeting prep.
• Translate regulatory guidance into practical plans, including eCTD submissions and post-approval activities.
• Collaborate with clients and cross-functional teams and mentor junior team members.

Skills

Regulatory knowledge

Mentoring

Education

B.Sc., M.Sc., or equivalent degree in science

Job description

Allucent is seeking a Regulatory Affairs Scientist I to support regulatory activities for drug, biologic, or device programs and contribute to project teams across roles such as Subject matter Expert and Consulting Lead.

You will prepare regulatory documents, assist with HA interactions, and translate guidance into practical plans, including eCTD submissions, while mentoring junior members and staying current with evolving regulations. Hybrid work options available.